{
"description": "Profile of Composition for Evidence Based Medicine IG. The M11Report Profile is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.",
"_filename": "StructureDefinition-m11-report.json",
"package_name": "hl7.fhir.uv.ebm",
"date": "2023-12-17T16:55:23+00:00",
"derivation": "constraint",
"publisher": "HL7 International / Clinical Decision Support",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "M11Report",
"mapping": [ {
"uri": "http://hl7.org/fhir/workflow",
"name": "Workflow Pattern",
"identity": "workflow"
}, {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
}, {
"uri": "http://hl7.org/v3/cda",
"name": "CDA (R2)",
"identity": "cda"
}, {
"uri": "http://hl7.org/fhir/documentreference",
"name": "FHIR DocumentReference",
"identity": "fhirdocumentreference"
} ],
"abstract": false,
"type": "Composition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": null,
"package_version": "1.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "cds"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "draft"
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
} ],
"expression": "text.`div`.exists()"
} ],
"path": "Composition",
"min": 0,
"definition": "A set of healthcare-related information that is assembled together into a single logical package that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. A Composition defines the structure and narrative content necessary for a document. However, a Composition alone does not constitute a document. Rather, the Composition must be the first entry in a Bundle where Bundle.type=document, and any other resources referenced from Composition must be included as subsequent entries in the Bundle (for example Patient, Practitioner, Encounter, etc.).",
"isModifier": false,
"short": "A set of resources composed into a single coherent clinical statement with clinical attestation",
"mapping": [ {
"map": "Entity, Role, or Act,Document[classCode=\"DOC\" and moodCode=\"EVN\" and isNormalAct()]",
"identity": "rim"
}, {
"map": "Event",
"identity": "workflow"
}, {
"map": "infrastructure.documents",
"identity": "w5"
}, {
"map": "ClinicalDocument",
"identity": "cda"
}, {
"map": "when described by DocumentReference",
"identity": "fhirdocumentreference"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition",
"comment": "While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.",
"base": {
"max": "*",
"min": 0,
"path": "Composition"
},
"isSummary": false
}, {
"path": "Composition.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"isModifier": false,
"short": "Logical id of this artifact",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.id",
"comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.meta",
"min": 0,
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"isModifier": false,
"short": "Metadata about the resource",
"type": [ {
"code": "Meta"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.implicitRules",
"min": 0,
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"isModifier": true,
"short": "A set of rules under which this content was created",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.implicitRules",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.implicitRules"
},
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "Composition.language",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"base": {
"max": "1",
"min": 0,
"path": "Resource.language"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.text",
"min": 0,
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"isModifier": false,
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "Composition.text",
"condition": [ "dom-6" ],
"comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"base": {
"max": "1",
"min": 0,
"path": "DomainResource.text"
},
"isSummary": false
}, {
"path": "Composition.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"isModifier": false,
"short": "Contained, inline Resources",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"mustSupport": false,
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "Composition.contained",
"condition": [ "dom-2", "dom-4", "dom-3", "dom-5" ],
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.contained"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.extension",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "Indicates the mechanism used to compare versions to determine which is more current.",
"isModifier": false,
"short": "How to compare versions",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm" ]
} ],
"mustSupport": false,
"sliceName": "versionAlgorithm",
"max": "1",
"id": "Composition.extension:versionAlgorithm",
"comment": "If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "A Boolean value to indicate that this {{title}} is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.",
"isModifier": false,
"short": "For testing purposes, not real usage",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-experimental" ]
} ],
"mustSupport": false,
"sliceName": "experimental",
"max": "1",
"id": "Composition.extension:experimental",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "A free text natural language description of the {{title}} from a consumer's perspective.",
"isModifier": false,
"short": "Natural language description of the {{title}}",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-description" ]
} ],
"mustSupport": false,
"sliceName": "description",
"max": "1",
"id": "Composition.extension:description",
"comment": "This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the {{title}} as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the {{title}} is presumed to be the predominant language in the place the {{title}} was created).",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "Explanation of why this {{title}} is needed and why it has been designed as it has.",
"isModifier": false,
"short": "Why this {{title}} is defined",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-purpose" ]
} ],
"mustSupport": false,
"sliceName": "purpose",
"max": "1",
"id": "Composition.extension:purpose",
"comment": "This element does not describe the usage of the {{title}}. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this {{title}}.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "A copyright statement relating to the {{title}} and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the {{title}}.",
"isModifier": false,
"short": "Use and/or publishing restrictions",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-copyright" ]
} ],
"mustSupport": false,
"sliceName": "copyright",
"max": "1",
"id": "Composition.extension:copyright",
"comment": "The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').",
"isModifier": false,
"short": "Copyright holder and year(s)",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel" ]
} ],
"mustSupport": false,
"sliceName": "copyrightLabel",
"max": "1",
"id": "Composition.extension:copyrightLabel",
"comment": "Defines the content expected to be rendered in all representations of the artifact. The (c) symbol should NOT be included in this string. It is expected to be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.",
"isModifier": false,
"short": "When the resource was approved by publisher",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-approvalDate" ]
} ],
"mustSupport": false,
"sliceName": "approvalDate",
"max": "1",
"id": "Composition.extension:approvalDate",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.",
"isModifier": false,
"short": "When the resource was last reviewed by the publisher",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-lastReviewDate" ]
} ],
"mustSupport": false,
"sliceName": "lastReviewDate",
"max": "1",
"id": "Composition.extension:lastReviewDate",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.extension",
"min": 0,
"definition": "The period during which the resource content was or is planned to be in active use.",
"isModifier": false,
"short": "When the resource is expected to be used",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-effectivePeriod" ]
} ],
"mustSupport": false,
"sliceName": "effectivePeriod",
"max": "1",
"id": "Composition.extension:effectivePeriod",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.url",
"requirements": "Allows the Composition to be referenced by a single globally unique identifier.",
"min": 0,
"definition": "An absolute URI that is used to identify this Composition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this Composition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the Composition is stored on different servers.",
"isModifier": false,
"short": "Canonical identifier for this Composition, represented as a URI (globally unique)",
"mapping": [ {
"map": "FiveWs.identifier",
"identity": "w5"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.url",
"comment": "Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.identifier",
"min": 0,
"definition": "A version-independent identifier for the Composition. This identifier stays constant as the composition is changed over time.",
"isModifier": false,
"short": "Version-independent identifier for the Composition",
"mapping": [ {
"map": "Event.identifier",
"identity": "workflow"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
}, {
"map": "Document.id / Document.setId",
"identity": "rim"
}, {
"map": ".setId",
"identity": "cda"
}, {
"map": "DocumentReference.identifier",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.identifier",
"comment": "Similar to ClinicalDocument/setId in CDA. See discussion in resource definition for how these relate.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.version",
"min": 0,
"definition": "An explicitly assigned identifer of a variation of the content in the Composition.",
"isModifier": false,
"short": "An explicitly assigned identifer of a variation of the content in the Composition",
"mapping": [ {
"map": "FiveWs.version",
"identity": "w5"
}, {
"map": ".versionNumber",
"identity": "cda"
}, {
"map": "DocumentReference.version",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.version",
"comment": "While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the Composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.status",
"requirements": "Need to be able to mark interim, amended, or withdrawn compositions or documents.",
"min": 1,
"definition": "The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.",
"isModifier": true,
"short": "registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown",
"mapping": [ {
"map": "Event.status",
"identity": "workflow"
}, {
"map": "FiveWs.status",
"identity": "w5"
}, {
"map": "interim: .completionCode=\"IN\" & ./statusCode[isNormalDatatype()]=\"active\"; final: .completionCode=\"AU\" && ./statusCode[isNormalDatatype()]=\"complete\" and not(./inboundRelationship[typeCode=\"SUBJ\" and isNormalActRelationship()]/source[subsumesCode(\"ActClass#CACT\") and moodCode=\"EVN\" and domainMember(\"ReviseComposition\", code) and isNormalAct()]); amended: .completionCode=\"AU\" && ./statusCode[isNormalDatatype()]=\"complete\" and ./inboundRelationship[typeCode=\"SUBJ\" and isNormalActRelationship()]/source[subsumesCode(\"ActClass#CACT\") and moodCode=\"EVN\" and domainMember(\"ReviseComposition\", code) and isNormalAct() and statusCode=\"completed\"]; withdrawn : .completionCode=NI && ./statusCode[isNormalDatatype()]=\"obsolete\"",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
}, {
"map": "DocumentReference.docStatus",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/composition-status|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionStatus"
} ],
"description": "The workflow/clinical status of the composition."
},
"max": "1",
"id": "Composition.status",
"comment": "If a composition is marked as withdrawn, the compositions/documents in the series, or data from the composition or document series, should never be displayed to a user without being clearly marked as untrustworthy. The flag \"entered-in-error\" is why this element is labeled as a modifier of other elements. \n\nSome reporting work flows require that the original narrative of a final document never be altered; instead, only new narrative can be added. The composition resource has no explicit status for explicitly noting whether this business rule is in effect. This would be handled by an extension if required.",
"base": {
"max": "1",
"min": 1,
"path": "Composition.status"
},
"isModifierReason": "This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.type",
"requirements": "Key metadata element describing the composition, used in searching/filtering.",
"min": 1,
"definition": "Specifies the particular kind of composition (e.g. History and Physical, Discharge Summary, Progress Note). This usually equates to the purpose of making the composition.",
"isModifier": false,
"short": "Kind of composition (LOINC if possible)",
"mapping": [ {
"map": "Event.code",
"identity": "workflow"
}, {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
}, {
"map": "DocumentReference.type",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-typecodes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DocumentType"
} ],
"description": "Type of a composition."
},
"max": "1",
"id": "Composition.type",
"comment": "For Composition type, LOINC is ubiquitous and strongly endorsed by HL7. Most implementation guides will require a specific LOINC code, or use LOINC as an extensible binding.",
"base": {
"max": "1",
"min": 1,
"path": "Composition.type"
},
"isSummary": true
}, {
"path": "Composition.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 1,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "1",
"id": "Composition.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"patternCoding": {
"code": "EvidenceReport",
"system": "https://fevir.net/resources/CodeSystem/179423",
"display": "EvidenceReport"
},
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.category",
"requirements": "Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.",
"min": 1,
"definition": "A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.",
"isModifier": false,
"short": "Categorization of Composition",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": ".outboundRelationship[typeCode=\"COMP].target[classCode=\"LIST\", moodCode=\"EVN\"].code",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
}, {
"map": "DocumenttReference.category",
"identity": "fhirdocumentreference"
} ],
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "text",
"type": "value"
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/referenced-item-category",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DocumentCategory"
} ],
"description": "High-level kind of a clinical document at a macro level."
},
"max": "*",
"id": "Composition.category",
"base": {
"max": "*",
"min": 0,
"path": "Composition.category"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.category",
"requirements": "Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.",
"min": 1,
"definition": "A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.",
"isModifier": false,
"short": "Categorization of Composition",
"mapping": [ {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": ".outboundRelationship[typeCode=\"COMP].target[classCode=\"LIST\", moodCode=\"EVN\"].code",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
}, {
"map": "DocumenttReference.category",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "m11report",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/referenced-item-category",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DocumentCategory"
} ],
"description": "High-level kind of a clinical document at a macro level."
},
"max": "1",
"id": "Composition.category:m11report",
"base": {
"max": "*",
"min": 0,
"path": "Composition.category"
},
"isSummary": true
}, {
"path": "Composition.category.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.category:m11report.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.category.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.category:m11report.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.category.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.category:m11report.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.category.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "CeSHarP Report",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.category:m11report.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.subject",
"requirements": "Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about.",
"min": 0,
"definition": "Who or what the composition is about. The composition can be about a person, (patient or healthcare practitioner), a device (e.g. a machine) or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).",
"isModifier": false,
"short": "Who and/or what the composition is about",
"mapping": [ {
"map": "Event.subject",
"identity": "workflow"
}, {
"map": "FiveWs.subject[x]",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"SBJ\"].role[typeCode=\"PAT\"]",
"identity": "rim"
}, {
"map": ".recordTarget",
"identity": "cda"
}, {
"map": "DocumentReference.subject",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Citation", "http://hl7.org/fhir/uv/ebm/StructureDefinition/classification", "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-report-subject", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.subject",
"comment": "Reference a single Citation Resource, EvidenceVariable Resource (EvidenceReportSubject Profile), or ReserchStudy Resource to define the subject of this EvidenceReport.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.subject"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.encounter",
"requirements": "Provides context for the composition and supports searching.",
"min": 0,
"definition": "Describes the clinical encounter or type of care this documentation is associated with.",
"isModifier": false,
"short": "Context of the Composition",
"mapping": [ {
"map": "Event.encounter",
"identity": "workflow"
}, {
"map": "FiveWs.context",
"identity": "w5"
}, {
"map": "unique(highest(./outboundRelationship[typeCode=\"SUBJ\" and isNormalActRelationship()], priorityNumber)/target[moodCode=\"EVN\" and classCode=(\"ENC\", \"PCPR\") and isNormalAct])",
"identity": "rim"
}, {
"map": ".componentOf.encompassingEncounter",
"identity": "cda"
}, {
"map": "DocumentReference.context",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Encounter" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.encounter",
"base": {
"max": "1",
"min": 0,
"path": "Composition.encounter"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.date",
"requirements": "dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, [Bundle.timestamp](bundle-definitions.html#Bundle.timestamp) is the date of packaging.",
"min": 1,
"definition": "The composition editing time, when the composition was last logically changed by the author.",
"isModifier": false,
"short": "Composition editing time",
"mapping": [ {
"map": "Event.occurrence[x]",
"identity": "workflow"
}, {
"map": "FiveWs.done[x]",
"identity": "w5"
}, {
"map": ".effectiveTime[type=\"TS\"]",
"identity": "rim"
}, {
"map": ".effectiveTime",
"identity": "cda"
}, {
"map": "DocumentReference.content.attachment.date, DocumentReference.date",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.date",
"comment": "The Last Modified Date on the composition may be after the date of the document was attested without being changed. This means that the date on an amended document is the date of the amendment, not the date of original authorship.",
"base": {
"max": "1",
"min": 1,
"path": "Composition.date"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.useContext",
"requirements": "Assist in searching for appropriate content.",
"min": 0,
"definition": "The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate Composition instances.",
"isModifier": false,
"short": "The context that the content is intended to support",
"type": [ {
"code": "UsageContext"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.useContext",
"comment": "When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.useContext"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.author",
"requirements": "Identifies who is responsible for the content.",
"min": 1,
"definition": "Identifies who is responsible for the information in the composition, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the composition",
"mapping": [ {
"map": "Event.performer",
"identity": "workflow"
}, {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
}, {
"map": "DocumentReference.author",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.author",
"base": {
"max": "*",
"min": 1,
"path": "Composition.author"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.name",
"requirements": "Support human navigation and code generation.",
"min": 0,
"definition": "A natural language name identifying the {{title}}. This name should be usable as an identifier for the module by machine processing applications such as code generation.",
"isModifier": false,
"short": "Name for this Composition (computer friendly)",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.name",
"comment": "The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.title",
"min": 1,
"definition": "Official human-readable label for the composition.",
"isModifier": false,
"short": "Human Readable name/title",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
}, {
"map": "DocumentReference.description, DocumentReference.content.attachment.title",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.title",
"comment": "For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a \"consultation\" or \"progress note\"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.",
"base": {
"max": "1",
"min": 1,
"path": "Composition.title"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.note",
"min": 0,
"definition": "For any additional notes.",
"isModifier": false,
"short": "For any additional notes",
"type": [ {
"code": "Annotation"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.note",
"comment": "A comment, general note or annotation not coded elsewhere.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.note"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.attester",
"requirements": "Identifies responsibility for the accuracy of the composition content.",
"min": 0,
"definition": "A participant who has attested to the accuracy of the composition/document.",
"isModifier": false,
"short": "Attests to accuracy of composition",
"mapping": [ {
"map": ".participation[typeCode=\"AUTHEN\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".authenticator/.legalAuthenticator",
"identity": "cda"
}, {
"map": "DocumentReference.attester",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.attester",
"comment": "Only list each attester once.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.attester"
},
"isSummary": false
}, {
"path": "Composition.attester.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.attester.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.attester.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.attester.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.attester.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.attester.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.attester.mode",
"requirements": "Indicates the level of authority of the attestation.",
"min": 1,
"definition": "The type of attestation the authenticator offers.",
"isModifier": false,
"short": "reviewer | editor | endorser | informant",
"mapping": [ {
"map": "unique(./modeCode)",
"identity": "rim"
}, {
"map": "implied by .authenticator/.legalAuthenticator",
"identity": "cda"
}, {
"map": "DocumentReference.attester.mode",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/contributor-role"
},
"max": "1",
"id": "Composition.attester.mode",
"base": {
"max": "1",
"min": 1,
"path": "Composition.attester.mode"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.attester.time",
"requirements": "Identifies when the information in the composition was deemed accurate. (Things may have changed since then.).",
"min": 0,
"definition": "When the composition was attested by the party.",
"isModifier": false,
"short": "When the composition was attested",
"mapping": [ {
"map": "./time[type=\"TS\" and isNormalDatatype()]",
"identity": "rim"
}, {
"map": ".authenticator.time",
"identity": "cda"
}, {
"map": "DocumentReference.attester.time",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "dateTime"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.attester.time",
"base": {
"max": "1",
"min": 0,
"path": "Composition.attester.time"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.attester.party",
"requirements": "Identifies who has taken on the responsibility for accuracy of the composition content.",
"min": 0,
"definition": "Who attested the composition in the specified way.",
"isModifier": false,
"short": "Who attested the composition",
"mapping": [ {
"map": "FiveWs.witness",
"identity": "w5"
}, {
"map": "./role[classCode=\"ASSIGNED\" and isNormalRole]/player[determinerCode=\"INST\" and classCode=(\"DEV\", \"PSN\") and isNormalEntity()] or ./role[classCode=\"ASSIGNED\" and isNormalRole and not(player)]/scoper[determinerCode=\"INST\" and classCode=\"ORG\" and isNormalEntity()]",
"identity": "rim"
}, {
"map": ".authenticator.assignedEnttty",
"identity": "cda"
}, {
"map": "DocumentReference.attester.party",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.attester.party",
"base": {
"max": "1",
"min": 0,
"path": "Composition.attester.party"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.custodian",
"requirements": "Identifies where to go to find the current version, where to report issues, etc.",
"min": 0,
"definition": "Identifies the organization or group who is responsible for ongoing maintenance of and access to the composition/document information.",
"isModifier": false,
"short": "Organization which maintains the composition",
"mapping": [ {
"map": ".participation[typeCode=\"RCV\"].role[classCode=\"CUST\"].scoper[classCode=\"ORG\" and determinerCode=\"INST\"]",
"identity": "rim"
}, {
"map": ".custodian.assignedCustodian",
"identity": "cda"
}, {
"map": "DocumentReference.custodian",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.custodian",
"comment": "This is useful when documents are derived from a composition - provides guidance for how to get the latest version of the document. This is optional because this is sometimes not known by the authoring system, and can be inferred by context. However, it is important that this information be known when working with a derived document, so providing a custodian is encouraged.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.custodian"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.relatesTo",
"min": 0,
"definition": "Relationships that this composition has with other compositions or documents that already exist.",
"isModifier": false,
"short": "Relationships to other compositions/documents",
"mapping": [ {
"map": ".outboundRelationship",
"identity": "rim"
}, {
"map": ".relatedDocument",
"identity": "cda"
}, {
"map": "DocumentReference.relatesTo",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.relatesTo",
"comment": "To reference (using relatesTo) a Bundle of type \"document\" or another Composition where you only have the identifier, use a resourceReference with an identifier.\\\nWhen a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource. \nHere is an example of using relatesTo to reference another Bundle of type \"document\" or Composition where you only have the identifier:\n```\n\"relatesTo\": [{\n \"type\": \"replaces\",\n \"resourceReference\": {\n \"identifier\": { \n \"system\": \"...\", \n \"value\": \"...\"\n }\n } \n}]\n```",
"base": {
"max": "*",
"min": 0,
"path": "Composition.relatesTo"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.event",
"requirements": "Provides context for the composition and creates a linkage between a resource describing an event and the composition created describing the event.",
"min": 0,
"definition": "The clinical service, such as a colonoscopy or an appendectomy, being documented.",
"isModifier": false,
"short": "The clinical service(s) being documented",
"mapping": [ {
"map": "outboundRelationship[typeCode=\"SUBJ\"].target[classCode<'ACT']",
"identity": "rim"
}, {
"map": ".documentationOf.serviceEvent",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.event",
"comment": "The event needs to be consistent with the type element, though can provide further information if desired.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.event"
},
"isSummary": true
}, {
"path": "Composition.event.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.event.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.event.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.event.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.event.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.event.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.event.period",
"min": 0,
"definition": "The period of time covered by the documentation. There is no assertion that the documentation is a complete representation for this period, only that it documents events during this time.",
"isModifier": false,
"short": "The period covered by the documentation",
"mapping": [ {
"map": ".effectiveTime",
"identity": "rim"
}, {
"map": ".effectiveTime",
"identity": "cda"
}, {
"map": "DocumentReference.period",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.event.period",
"base": {
"max": "1",
"min": 0,
"path": "Composition.event.period"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.event.detail",
"min": 0,
"definition": "Represents the main clinical acts, such as a colonoscopy or an appendectomy, being documented. In some cases, the event is inherent in the typeCode, such as a \"History and Physical Report\" in which case the procedure being documented is necessarily a \"History and Physical\" act. The events may be included as a code or as a reference to an other resource.",
"isModifier": false,
"short": "The event(s) being documented, as code(s), reference(s), or both",
"mapping": [ {
"map": ".outboundRelationship[typeCode=\"SUBJ\"].target",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
}, {
"map": "DocumentReference.event",
"identity": "fhirdocumentreference"
} ],
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://terminology.hl7.org/ValueSet/v3-ActCode",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DocumentEventType"
} ],
"description": "This list of codes represents the main clinical acts being documented."
},
"max": "*",
"id": "Composition.event.detail",
"comment": "An event can further specialize the act inherent in the typeCode, such as where it is simply \"Procedure Report\" and the procedure was a \"colonoscopy\". If one or more events are included, they SHALL NOT conflict with the values inherent in the classCode, practiceSettingCode or typeCode, as such a conflict would create an ambiguous situation. This short list of codes is provided to be used as key words for certain types of queries.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.event.detail"
},
"isSummary": true
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 15,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "summary",
"max": "1",
"id": "Composition.section:summary",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Protocol Summary",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:summary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1-protocol-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "protocolSynopsis",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Protocol Synopsis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1.1-protocol-synopsis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 6,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "objectivesEndpoints",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Primary and Secondary Objectives and Endpoints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1.1.1-objectives-endpoints",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.text",
"condition": [ "cmp-1" ],
"comment": "Include a copy of the Objectives/Endpoints Table including primary and secondary endpoints only from Section 3 of the protocol and follow all the same instructions. Not all trials will have a complete estimand. Do not include exploratory endpoints in the synopsis.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Composition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "overallDesign",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Overall Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1.1.2-overall-design",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.text",
"condition": [ "cmp-1" ],
"comment": "see Template instructions",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Composition", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "numberOfArms",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Number of Arms",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.text",
"condition": [ "cmp-1" ],
"comment": "Enter the numeric value for the number of arms in the trial. For trials with a different number of arms in different periods, populate this field based on the total number of arms.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "blinding",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Blinding",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.text",
"condition": [ "cmp-1" ],
"comment": "For designs in which these details may differ in one or more trial periods, answer according to the portion of the trial in which the highest number of blinded roles occurs. More details can be provided in Section 6.6 of the protocol. Blinded roles: The following roles indicated will not be made aware of the treatment group assignment during the trial: [blinded roles] Not applicable (No blinding) indicates an open-label trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "numberOfParticipants",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Number of Participants",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.text",
"condition": [ "cmp-1" ],
"comment": "State the expected number of participants to be assigned to trial intervention/enrolled. Indicate whether the number provided is the target or maximum number of individuals to be randomly assigned to trial intervention/enrolled. A [Target/ Maximum] of [[Enter Number of Participants]] participants will be [randomly assigned to trial intervention/ enrolled].",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "duration",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Arms and Duration",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.text",
"condition": [ "cmp-1" ],
"comment": "See Template instructions.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "committees",
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Committees",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.text",
"condition": [ "cmp-1" ],
"comment": "Indicate whether any committee(s) will be reviewing data while the trial is ongoing, and the type of committee. Common examples include Data Monitoring Committee, Dose Escalation Committee, or Endpoint Adjudication Committee; describe others, if applicable. List independent committees in the space indicated. Other committees may be included at the Sponsor’s discretion in the separate space provided. Committees listed here should be fully described in Section 11.3. Indicate N/A if no independent committees will be involved in the trial. Delete Other Committees if not applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "trialSchema",
"max": "1",
"id": "Composition.section:summary.section:trialSchema",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:trialSchema.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:trialSchema.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:trialSchema.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Schema",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:trialSchema.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:trialSchema.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:trialSchema.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:trialSchema.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:trialSchema.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1.2-trial-schema",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:trialSchema.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:trialSchema.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:trialSchema.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:trialSchema.text",
"condition": [ "cmp-1" ],
"comment": "The purpose of this section is to provide a visual depiction of the trial design, orienting users of the protocol to the key features of the design. The schema depicts the trial arms, the flow of individual participants through the progression of trial period(s)/epochs (such as screening, washout/run-in, intervention, and key milestones [for example, randomisation, cross-over, end of treatment]). For complex trials, additional schemas may be added to describe activities or trial periods in greater detail.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:trialSchema.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:trialSchema.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:trialSchema.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:trialSchema.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "scheduleOfActivities",
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Schedule of Activities",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section1.3-schedule-of-activities",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.text",
"condition": [ "cmp-1" ],
"comment": "The schedule of activities must capture the procedures that will be accomplished at each trial visit, and all contact with participants, for example, telephone contacts. This includes any tests that are used for eligibility, participant randomisation or stratification, or decisions on trial intervention discontinuation. Allowable windows should be stated for all visits and procedures. A tabular format is recommended.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:summary.section:scheduleOfActivities.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:summary.section:scheduleOfActivities.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "introduction",
"max": "1",
"id": "Composition.section:introduction",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Introduction",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:introduction.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2-introduction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 2,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "purposeOfTrial",
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Purpose of Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.1-trial-purpose",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.text",
"condition": [ "cmp-1" ],
"comment": "Explain why the trial is needed, why the research questions being asked are important. Do not restate the IB.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:purposeOfTrial.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:purposeOfTrial.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "benefitsAndRisks",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Summary of Benefits and Risks",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2-benefits-risks",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "benefitSummary",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Benefit Summary",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.1-benefit-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.text",
"condition": [ "cmp-1" ],
"comment": "The benefit summary should be written from the perspective of an individual participant, and should describe any physical, psychological, social, legal, or any other potential benefits to individual participants as a result of participating in the trial, addressing immediate potential benefits and/or long-range potential benefits. Clearly state if no benefits to an individual participant can be anticipated, or if potential benefits are unknown. For early clinical trials such as Phase 1, benefits for an individual participant (other than those of altruism) are expected to be minimal. Benefits to society in general may also be included but should be described separately.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "riskSummary",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Risk Summary and Mitigation Strategy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.2-risk-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "trialIntervention",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial-specific Intervention Risks and Mitigations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.2.1-trial-intervention-risk-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.text",
"condition": [ "cmp-1" ],
"comment": "Trial Intervention - Describe risks related to trial-specific treatments and interventions. For the protocol, focus only on the relevant key risks for THIS trial. Provide a brief description of strategies to mitigate identified risks or provide a cross-reference to the relevant protocol section.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "trialProcedures",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial-specific Procedure Risks and Mitigations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.2.2-trial-procedures-risk-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.text",
"condition": [ "cmp-1" ],
"comment": "Trial Procedures - Consider risks associated with the design (for example, placebo arm) and procedures specific to THIS trial (for example, biopsies), and any measures to control the risks. Provide a brief description of strategies to mitigate identified risks or provide a cross-reference to the relevant protocol section. This is not intended to be an exhaustive list of all possible risks associated with trial procedures but should focus on the unique risks inherent in the design or less common or high-risk procedures. As above, provide a brief description of strategies to mitigate identified risks or provide a cross-reference to the relevant protocol section.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "otherRisk",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial-specific Other Risks and Mitigations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.2.3-trial-other-risk-summary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.text",
"condition": [ "cmp-1" ],
"comment": "Other - Consider risks associated with other items (for example, comparators, challenge agents, imaging agents, medical devices). Insert a line for each, as needed.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "overallBenefitRisk",
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Overall Benefit:Risk Conclusion",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section2.2.3-overall-benefit-risk-conclusion",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.text",
"condition": [ "cmp-1" ],
"comment": "Provide a succinct, concluding statement on the perceived balance between risks that have been identified from cumulative safety data, protocol procedures, and anticipated efficacy/benefits within the context of the proposed trial. Risks need to be assessed against the benefits for the individual participant at least once a year.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "endpoints",
"max": "*",
"id": "Composition.section:endpoints",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Objectives, Endpoints and Estimands",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:endpoints.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section3-endpoints",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "objectiveEndpoint",
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Objective + Associated Endpoint (and Estimand)",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section3.1-objective-endpoint-estimand",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 1,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "primarySecondaryExploratory",
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Primary/Secondary/Exploratory Classification",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Primary/Secondary/Exploratory",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.text",
"condition": [ "cmp-1" ],
"comment": "Enter 'Primary' or 'Secondary' or 'Exploratory' as the data value.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:primarySecondaryExploratory.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "objective",
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Objective",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Objective",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.text",
"condition": [ "cmp-1" ],
"comment": "Precisely define each clinical question of interest by stating each trial objective.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "endpoint",
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Endpoint",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Endpoint",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.text",
"condition": [ "cmp-1" ],
"comment": "Enter the description of the Endpoint (measured variable).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:endpoint.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "estimand",
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Estimand",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "Estimand",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.text",
"condition": [ "cmp-1" ],
"comment": "Describe the attributes that construct the estimand: the treatment condition of interest, the population of participants targeted by the clinical question of interest, other intercurrent events (if applicable), a population level summary, and the endpoint (or variable) specified in the table above.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "design",
"max": "1",
"id": "Composition.section:design",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:design.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4-trial-design",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "description",
"max": "1",
"id": "Composition.section:design.section:description",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:description.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:description.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:description.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Description of Trial Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:description.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:description.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:description.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:description.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:description.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.1-description-of-trial-design",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:description.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:description.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:description.text",
"condition": [ "cmp-1" ],
"comment": "see Template instructions",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:description.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:description.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "stakeholderInput",
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Stakeholder Input into Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.1.1-stakeholder-input-into-design",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any stakeholder (for example, patient, healthcare professional and patient advocacy groups) involvement in the design of the trial and any suggestions implemented.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:description.section:stakeholderInput.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:description.section:stakeholderInput.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "rationale",
"max": "1",
"id": "Composition.section:design.section:rationale",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Trial Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2-rationale-for-trial-design",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "model",
"max": "1",
"id": "Composition.section:design.section:rationale.section:model",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Intervention Model",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.1-rationale-intervention-model",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.text",
"condition": [ "cmp-1" ],
"comment": "Provide a rationale for the trial intervention model selected in Section 4.1, Description of Trial Design with a cross-reference to Section 6.2, Rationale for Investigational Intervention(s). Rationale for choice of comparator, if applicable, should be described separately in Section 4.2.5, Rationale for Comparator. A rationale for the choice of trial population should be described separately in Section 5.1, Description of Trial Population and Rationale.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:model.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:model.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "duration",
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Duration",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.2-rationale-duration",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.text",
"condition": [ "cmp-1" ],
"comment": "Provide a rationale that the trial duration is appropriate for a reliable and relevant evaluation of the trial intervention per the trial objective(s).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:duration.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:duration.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "endpoints",
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Endpoints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.3-rationale-endpoints",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.text",
"condition": [ "cmp-1" ],
"comment": "Provide a rationale that the trial endpoint(s) described in Section 3, Trial Objectives, Endpoints, and Estimands, are clinically relevant and provide a reliable and valid measurement of the intended intervention effect.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:endpoints.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:endpoints.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "interim",
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Interim Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.4-rationale-interim-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, provide a rationale for any interim analysis planned with respect to its purpose (for example, stopping the trial early for efficacy or futility) and timing.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:interim.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:interim.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "comparator",
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Comparator",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.5-rationale-comparator",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, provide a rationale for the type of control selected for the trial (for example, placebo, active drug, combination, historical). Describe any known or potential problems associated with the control group selected in light of the specific disease and intervention(s) being studied. If comparators will differ by region, describe.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:comparator.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:comparator.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "adaptive",
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Adaptive or Novel Trial Design",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.6-rationale-adaptive",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, provide a rationale for the use of an adaptive or novel design.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:adaptive.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:adaptive.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "otherAspects",
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Other Trial Design Aspects",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.2.7-rationale-other-aspects",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.text",
"condition": [ "cmp-1" ],
"comment": "Discuss rationale for any additional aspects of the design not addressed above.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:rationale.section:otherAspects.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:rationale.section:otherAspects.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "trialStoppingRules",
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Stopping Rules",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.3-trial-stopping-rules",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any trial-specific stopping rules, including guidance on when the trial should be stopped for safety reasons, when a cohort or dose escalation should be terminated, and/or when a given treatment arm should be terminated.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "temporaryHalt",
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Temporary Trial Halt",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.3.1-temporary-trial-halt",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe when any of the stopping rules may result in a temporary halt of enrollment into the trial and criteria for restarting enrollment.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "startEnd",
"max": "1",
"id": "Composition.section:design.section:startEnd",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:startEnd.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:startEnd.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:startEnd.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Start of Trial and End of Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:startEnd.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:startEnd.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:startEnd.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:startEnd.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:startEnd.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.4-start-and-end",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:startEnd.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:startEnd.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:startEnd.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:startEnd.text",
"condition": [ "cmp-1" ],
"comment": "Define key timepoints in the trial, including trial start and end dates. For example, a key timepoint definition for start of trial might be when the informed consent is signed by the first participant and a key timepoint definition for end of trial might be when participants are no longer being examined or the last participant’s last study assessment has occurred. If applicable, consider local regulatory requirements for these and other definitions (for example, the first act of recruitment). If appropriate, provide a cross-reference to Section 11.6",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:startEnd.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:startEnd.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:startEnd.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:startEnd.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "access",
"max": "1",
"id": "Composition.section:design.section:access",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:access.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:access.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:design.section:access.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Access to Trial Intervention After End of Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:design.section:access.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:design.section:access.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:design.section:access.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:design.section:access.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:design.section:access.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section4.5-access-after-trial",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:design.section:access.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:access.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:access.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:design.section:access.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any possibilities for access to trial intervention, if any, beyond completion of the trial. Planned extension trials, if described above in Section 4.1 do not need to be repeated.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:design.section:access.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:access.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:design.section:access.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:design.section:access.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "population",
"max": "1",
"id": "Composition.section:population",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Population",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:population.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5-trial-population",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 5,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "description",
"max": "1",
"id": "Composition.section:population.section:description",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:description.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:description.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:description.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Description of Trial Population and Rationale",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:description.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:description.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:description.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:description.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:description.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.1-population-description",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:description.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:description.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:description.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:description.text",
"condition": [ "cmp-1" ],
"comment": "Describe the population selected (for example, healthy participants, adult participants, paediatric participants) and how the enrollment criteria reflect the populations that are likely to use the drug if approved. Specify the population age range (for example, ≤3 months, ≥18 to ≤80 years old) including the time point at which qualification for age criteria is determined (for example, at time of screening vs randomization for paediatric trials). Specify any key diagnostic criteria for the population (for example, “acute lung injury”, or a specific biomarker profile). If applicable, describe similar conditions or diseases and their differential diagnosis. Provide a rationale for the trial population ensuring that the population selected is well defined and clinically recognisable. Describe how the selected population can meet the trial objectives and how the enrollment criteria reflects the targeted populations. Justify whether the trial intervention is to be evaluated in paediatric participants, in adults unable to consent for themselves, other vulnerable participant populations, or those that may respond to the trial intervention differently (for example, elderly, hepatic or renally impaired, or immunocompromised participants).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:description.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:description.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:description.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:description.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "inclusionCriteria",
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Inclusion Criteria",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.2-inclusion-criteria",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.text",
"condition": [ "cmp-1" ],
"comment": "Inclusion criteria are characteristics that define the trial population, for example, those criteria that every potential participant must satisfy, to qualify for trial entry.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:inclusionCriteria.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:inclusionCriteria.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "exclusionCriteria",
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Exclusion Criteria",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.3-exclusion-criteria",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.text",
"condition": [ "cmp-1" ],
"comment": "Exclusion criteria are characteristics that make an individual ineligible for participation.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:exclusionCriteria.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:exclusionCriteria.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "lifestyle",
"max": "1",
"id": "Composition.section:population.section:lifestyle",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Lifestyle Restrictions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.4-lifestyle-restrictions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.text",
"condition": [ "cmp-1" ],
"comment": "In the following subsections, describe any restrictions during the trial pertaining to lifestyle and/or diet, intake of caffeine, alcohol, or tobacco, or physical and other activities. If not applicable, include a statement that no restrictions are required.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "dietary",
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Meals and Dietary Restrictions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.4.1-dietary-restrictions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any restrictions on diet (for example, food and drink restrictions, timing of meals relative to dosing).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:dietary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:dietary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "substances",
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Caffeine, Alcohol, Tobacco, and Other Restrictions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.4.2-substances-restrictions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any restrictions on the intake of caffeine, alcohol, tobacco, or other restrictions.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:substances.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:substances.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "activity",
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Physical Activity Restrictions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.4.3-activity-restrictions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any restrictions on activity (for example, in first-in-human trials, activity may be restricted by ensuring participants remain in bed for 4 to 6 hours after dosing).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:activity.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:activity.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "other",
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Other Activity Restrictions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.4.4-other-restrictions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe restrictions on any other activity (for example, blood or tissue donation); or any other activity restrictions, such as on driving, heavy machinery use, or sun exposure.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:lifestyle.section:other.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:lifestyle.section:other.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "screenFailures",
"max": "1",
"id": "Composition.section:population.section:screenFailures",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:screenFailures.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:screenFailures.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:population.section:screenFailures.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Screen Failure and Rescreening",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:population.section:screenFailures.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:population.section:screenFailures.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:population.section:screenFailures.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:population.section:screenFailures.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:population.section:screenFailures.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section5.5-screen-failure",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:population.section:screenFailures.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:screenFailures.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:screenFailures.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:population.section:screenFailures.text",
"condition": [ "cmp-1" ],
"comment": "Indicate how screen failure will be handled in the trial, including conditions and criteria upon which rescreening is acceptable. If applicable, indicate the circumstances and time window under which a repeat procedure is allowed for screen failure relating to specific inclusion/exclusion criteria for the trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:population.section:screenFailures.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:screenFailures.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:population.section:screenFailures.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:population.section:screenFailures.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "intervention",
"max": "1",
"id": "Composition.section:intervention",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:intervention.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6-trial-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 8,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "description",
"max": "1",
"id": "Composition.section:intervention.section:description",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:description.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:description.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:description.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Description of Investigational Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:description.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:description.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:description.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:description.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:description.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.1-description-of-trial-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:description.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:description.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:description.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:description.text",
"condition": [ "cmp-1" ],
"comment": "The investigational trial intervention(s) should be described concisely in a table. Describe the investigational trial intervention to be administered in each arm of the trial and for each period of the trial including route and mode of administration, dose, dosage regimen, duration of intervention, use, packaging and labelling. Refer to approved regional labelling, as appropriate. For drug/device combination products, include details on the configuration and use of the device and device manufacturer. A device user manual may be referenced in this section.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:description.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:description.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:description.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:description.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "rationale",
"max": "1",
"id": "Composition.section:intervention.section:rationale",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:rationale.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:rationale.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:rationale.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rationale for Investigational Trial Intervention Dose and Regimen",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:rationale.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:rationale.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:rationale.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:rationale.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:rationale.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.2-rationale-for-trial-intervention-regimen",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:rationale.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:rationale.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:rationale.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:rationale.text",
"condition": [ "cmp-1" ],
"comment": "Provide a rationale for the selection of the dose(s) or dose range, the route of administration, and dosing regimen of the investigational trial intervention. This rationale should include relevant results from previous preclinical studies and clinical trials that support selection of the dose and regimen. Discuss impact of differences in study population characteristics (for example, age, sex and/or race) which could lead to differences in pharmacokinetics and pharmacodynamics in this study as compared to previous studies. If applicable, justify any differences in dose regimen or therapeutic use relative to approved labelling. Describe prior trials and other information that support the dose and/or dose regimen of the investigational intervention. Include a rationale for prospective dose adjustments incorporated in the trial, if any.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:rationale.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:rationale.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:rationale.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:rationale.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "dosingAdministration",
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Investigational Trial Intervention Administration",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.3-dosing-and-administration",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.text",
"condition": [ "cmp-1" ],
"comment": "Describe the detailed procedures for administration of each participant's dose of investigational trial intervention. This may include the timing of dosing (for example, time of day, interval), the duration (for example, the length of time participants will be administered the investigational trial intervention), the planned route of administration (for example, oral, nasal, intramuscular), and the timing of dosing relative to meals. Include any specific instructions to trial participants about when or how to prepare and take the dose(s) and how delayed or missed doses should be handled. Dose escalation or cohort expansion as part of the overall design should be covered in Section 4.1 (Description of Trial Design).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "doseModification",
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Investigational Trial Intervention Dose Modification",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.3.1-dose-modification",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.text",
"condition": [ "cmp-1" ],
"comment": "For each participant, describe any dose modifications allowed, including conditions for such dose modifications, particularly regarding failure to respond or safety concerns. State any minimum period required before a participant’s dose might be raised to the next higher dose or dose range. Include whether it is permissible to start and stop treatment and how dose reductions (if permitted) are to be managed. Information on stopping investigational trial intervention for an individua participant due to safety/other reasons should be detailed in Section 7, Participant Discontinuation of Trial Intervention and Withdrawal from Trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "treatmentOfOverdose",
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Management of Investigational Trial Intervention Overdose",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.4-management-of-overdose",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.text",
"condition": [ "cmp-1" ],
"comment": "Describe what is meant by investigational trial intervention overdose. Provide any available information on managing the overdose and ensure it is consistent with the Investigator’s Brochure or product labelling, cross-references these documents as applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition", "http://hl7.org/fhir/StructureDefinition/PlanDefinition" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:treatmentOfOverdose.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:treatmentOfOverdose.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "preparation",
"max": "1",
"id": "Composition.section:intervention.section:preparation",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.5-preparation-storage-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "preparationIntervention",
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Preparation of Investigational Trial Intervention(s)",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.5.1-preparation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.text",
"condition": [ "cmp-1" ],
"comment": "Describe any preparation of the investigational trial intervention, and when necessary, by whom. When applicable, describe the maximum hold time once thawed/mixed before administration. Include thawing, diluting, mixing, and reconstitution/preparation instructions in this section. For drug/device combination products, include any relevant assembly or use instructions and reference the package insert that is provided separately. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in a separate document(s) provided to the site (for example, a pharmacy manual). If the latter, reference the separate documents.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:preparationIntervention.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "storageHandling",
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Storage and Handling of Investigational Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.5.2-storage-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.text",
"condition": [ "cmp-1" ],
"comment": "Describe storage and handling requirements (for example, protection from light, temperature, humidity) for the investigational trial intervention(s). For trials in which multi-dose vials are utilised, provide additional information regarding stability and expiration time after initial use (for example, the seal is broken). State how the investigational trial intervention(s) will be provided to the Investigator. If applicable, describe the kits, packaging, or other material of the investigational trial intervention for blinding purposes. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in a separate document(s) provided to the site (for example, a pharmacy manual). If the latter, reference the separate documents.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:storageHandling.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "accountability",
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Accountability of Investigational Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.5.3-accountability",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.text",
"condition": [ "cmp-1" ],
"comment": "Describe the accountability method, including how the investigational trial intervention will be distributed and related details, including: •\thow and by whom the investigational trial intervention will be distributed •\tparticipation of a drug storage repository or pharmacy, if applicable, •\tplans for disposal or return of unused product, •\tif applicable, plans for reconciliation of investigational trial intervention.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:preparation.section:accountability.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:preparation.section:accountability.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "assignmentAndBlinding",
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Investigational Trial Intervention Assignment, Randomisation and Blinding",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.6-assignment-randomisation-blinding",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "assignment",
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Participant Assignment to Investigational Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.6.1-assignment",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.text",
"condition": [ "cmp-1" ],
"comment": "Describe the method of assigning participants to investigational trial intervention without being so specific that blinding or randomisation might be compromised. If assignment to investigational trial intervention is by randomisation, describe when randomisation occurs relative to screening. State that at enrollment, participant identification codes should be assigned. If adaptive randomisation or other methods of covariate balancing/minimisation are employed, include a cross-reference to the methods of analysis in Section 10, Statistical Considerations. As applicable, details regarding the implementation of procedures to minimise bias should be described.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "randomisation",
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Randomisation",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.6.2-randomisation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.text",
"condition": [ "cmp-1" ],
"comment": "Describe the randomisation procedures (for example, central randomisation procedures), the method used to generate the randomisation schedule (for example, computer generated), the source of the randomisation schedule (for example, sponsor, investigator, or other), and whether or not IxRS will be used. To maintain the integrity of the blinding, do not include the block size. Describe the use and validation of any computer systems and programmes used for randomisation.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "blinding",
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Blinding",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.6.3-blinding",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.text",
"condition": [ "cmp-1" ],
"comment": "Describe efforts to ensure that the investigational trial intervention(s) are as indistinguishable as possible. Plans for the maintenance of randomisation codes and appropriate blinding for the trial should be described. Procedures for planned and unplanned (for example, safety events) breaking of randomisation codes should be provided. If the trial allows for some investigators or other designated staff to remain unblinded (for example, to allow them to adjust investigational trial intervention), the means of maintaining the blinding for other investigators or staff should be explained. Measures to prevent unblinding by laboratory measurements or while performing study assessments, if used, should be described.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "unblinding",
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Emergency Unblinding at the Site",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.6.4-unblinding",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.text",
"condition": [ "cmp-1" ],
"comment": "Describe the criteria for breaking the trial blind or participant code. Describe the circumstances in which the blinding would be broken for an individual or for all participants and who has responsibility. Include the procedure for emergency unblinding such as via IxRS or code envelopes as well as documentation of unblinding. Indicate to whom the intentional and unintentional unblinding should be reported.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "compliance",
"max": "1",
"id": "Composition.section:intervention.section:compliance",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:compliance.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:compliance.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:compliance.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Investigational Trial Intervention Compliance",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:compliance.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:compliance.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:compliance.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:compliance.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:compliance.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.7-intervention-compliance",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:compliance.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:compliance.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:compliance.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:compliance.text",
"condition": [ "cmp-1" ],
"comment": "Describe measures employed to ensure and document dosing information and investigational trial intervention compliance (for example, accountability records, diary cards, or concentration measurements). Include a description of what documents are mandatory to complete (for example, participant drug log) and what source data/records will be used to document investigational trial intervention compliance.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:compliance.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:compliance.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:compliance.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:compliance.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "noninvestigationalTherapy",
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Non-Investigational Trial Intervention(s)",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.8-noninvestigational-interventions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "background",
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Background Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.8.1-background-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.text",
"condition": [ "cmp-1" ],
"comment": "Non-investigational interventions are products used in the context of the trial but are not part of trial objectives and are not investigational trial intervention. Describe background interventions, including administration and any conditions for use.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "rescue",
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rescue Therapy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.8.2-rescue-therapy",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.text",
"condition": [ "cmp-1" ],
"comment": "List all rescue medications, treatments, and/or procedures, including any relevant instructions about their administration and any conditions for their use. If administration of rescue therapy leads to the temporary discontinuation of trial intervention or a participant’s withdrawal from the trial, refer to Section 7, Participant Discontinuation of Trial Intervention and Withdrawal from Trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "other",
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Other Therapy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.8.3-other-therapy",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe the use of other non-investigational or auxiliary therapy, for example, challenge agents or diagnostics.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "concomitantTherapy",
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Concomitant Therapy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.9-concomitant-therapy",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.text",
"condition": [ "cmp-1" ],
"comment": "Describe the concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures which are allowed or prohibited during the trial, and include details about when the information will be collected (for example, screening, all visits). This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "prohibited",
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Prohibited Concomitant Therapy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.9.1-prohibited-concomitant-therapy",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any prohibited concomitant therapy.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "permitted",
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Permitted Concomitant Therapy",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section6.9.2-permitted-concomitant-therapy",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any permitted concomitant therapy.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:intervention.section:concomitantTherapy.section:permitted.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "dropout",
"max": "1",
"id": "Composition.section:dropout",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Participant Discontinuation of Trial Intervention and Withdrawal from Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:dropout.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7-participant-discontinuation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "discontinuation",
"max": "1",
"id": "Composition.section:dropout.section:discontinuation",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Discontinuation of Trial Intervention for Individual Participants",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.1-discontinuation-of-trial-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "permanent",
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Permanent Discontinuation of Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.1.1-permanent-discontinuation-of-trial-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.text",
"condition": [ "cmp-1" ],
"comment": "Discontinuation of trial intervention for a participant occurs when trial intervention is stopped earlier than the protocol planned duration. Describe the criteria for discontinuation of a participant from any trial intervention, carefully evaluating which are appropriate for the trial population and therapy being studied. Specify whether participants who discontinue trial intervention can or cannot continue the trial (continue trial visits). Refer to the Section 1.3 Schedule of Activities for assessments to be performed at the time of and following discontinuation of trial intervention. Explain the process for collecting and recording the detailed reasons for discontinuing trial intervention(s).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:permanent.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "temporary",
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Temporary Discontinuation of Trial Intervention",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.1.2-temporary-discontinuation-of-trial-intervention",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.text",
"condition": [ "cmp-1" ],
"comment": "Describe •\tthe criteria for temporary discontinuation or interruption of trial intervention for an individual participant •\twhat to do and which restrictions still apply if the participant needs to temporarily discontinue or interrupt trial intervention •\twhether they will continue in the trial, and • whether all, or specify which, assessments will be performed for the stated duration of the trial. Details of any rechallenge or restart after a safety-related event should be included in Section 7.1.3, Rechallenge.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:temporary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "rechallenge",
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Rechallenge",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.1.3-rechallenge",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.text",
"condition": [ "cmp-1" ],
"comment": "Describe the criteria for rechallenge/restarting trial intervention, how to perform rechallenge, number of rechallenges allowed during the trial, and whether all, or specify which, assessments will be performed for the stated duration of the trial. If rechallenge is not allowed, state this.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "withdrawal",
"max": "1",
"id": "Composition.section:dropout.section:withdrawal",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Withdrawal from the Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.2-participant-withdrawal",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.text",
"condition": [ "cmp-1" ],
"comment": "Describe the criteria for participant withdrawal from the trial. Describe the reason for withdrawal and the type and data to be collected for the final assessments with reference to the schedule of activities for the participant end of study visit unless provided in another section.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:withdrawal.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:withdrawal.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "lostToFollowUp",
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Lost to Follow-Up",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.3-lost-to-follow-up",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.text",
"condition": [ "cmp-1" ],
"comment": "Describe the measures to be taken to reduce the frequency of participants lost to follow up. Describe how the trial will define and address participants who are lost to follow-up to help limit the amount and impact of missing data. Describe the nature and duration of follow-up, as appropriate.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:lostToFollowUp.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:lostToFollowUp.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "trialStoppingRules",
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Participant Stopping Rules",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section7.4-participant-stopping-rules",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.text",
"condition": [ "cmp-1" ],
"comment": "If applicable, describe any trial-specific stopping rules that would apply to individual participants such as treatment or study non-compliance or due to safety reasons. Address the procedure ensuring alignment with the intercurrent events and their handling strategies introduced in Section 3.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:dropout.section:trialStoppingRules.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:dropout.section:trialStoppingRules.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "assessments",
"max": "1",
"id": "Composition.section:assessments",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Assessments and Procedures",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:assessments.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.text",
"condition": [ "cmp-1" ],
"comment": "• Describe the assessments and procedures required during each phase of the trial. Provide details that are not already presented in the SoA, taking care not to duplicate information. •\tDescribe methods, training, tools, instruments/questionnaires, calibration methods, etc. that will be used to record and assess data and ensure consistency across centres and participants. Include instructions on timing/conditions of assessments and if a specifically qualified person should be performing these assessments. Describe whether centralised readings and measurements will be utilised. •\tReference the literature for the validation of scales/instruments/questionnaires/assays. •\tInstructions or protocols for specialised tests and scales/instruments/questionnaires/assays may be presented in an appendix or a separate document and cross-referenced. •\tIf the trial includes qualitative interviews, describe these evaluations. •\tIf COA measures are utilised, include instructions for the investigators per local guidance. All descriptions related to COA parameters should be fully integrated into the appropriate sections of the protocol; separate COA sections should not be created in the protocol. •\tInclude minimums and limits for procedures (for example, number of imaging procedures/biopsies, radiation exposure, etc.) if appropriate to the trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 8,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "screeningBaseline",
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Screening/Baseline Assessments and Procedures",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.1-screening-baseline-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.text",
"condition": [ "cmp-1" ],
"comment": "Describe any assessments and procedures that are unique to screening/baseline (for example, collection of data on participant characteristics, assessments/procedures performed for the purpose of determining eligibility or for stratification) in this section. Describe screening and baseline assessments and procedures separately if screening and baseline are performed at different visits.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:screeningBaseline.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:screeningBaseline.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "efficacy",
"max": "1",
"id": "Composition.section:assessments.section:efficacy",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:efficacy.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:efficacy.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:efficacy.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Efficacy Assessments and Procedures",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:efficacy.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:efficacy.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:efficacy.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:efficacy.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:efficacy.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.2-efficacy-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:efficacy.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:efficacy.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:efficacy.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:efficacy.text",
"condition": [ "cmp-1" ],
"comment": "Describe efficacy assessments and procedures in this section. Cross-refer to Section 8.7 if immunogenicity assessments are used in efficacy determination.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:efficacy.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:efficacy.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:efficacy.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:efficacy.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "safety",
"max": "1",
"id": "Composition.section:assessments.section:safety",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Safety Assessments and Procedures",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3-safety-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "physical",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Physical Examination",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.1-physical-examination",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection and interpretation of physical examinations.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:physical.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:physical.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "vitals",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Vital Signs",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.2-vital-signs",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection and interpretation of vital signs.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:vitals.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:vitals.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "ecg",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Electrocardiograms",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.3-electrocardiograms",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection, interpretation, and archiving of ECGs.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:ecg.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:ecg.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "laboratory",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Clinical Laboratory Assessments",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.4-clinical-laboratory-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection and interpretation of clinical laboratory assessments. •\tType of laboratory (central/local/hybrid) •\tacceptability of additional tests deemed necessary by the investigator or local regulations •\tinstructions for situations in which central laboratory results are not available in time for trial intervention and/or response evaluation, or in the event of a severe disruption (for example, a pandemic or natural disaster) •\ttreatment algorithms for results out of normal range •\tCross-refer to Section 13.2 for lab assessment panels",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:laboratory.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:laboratory.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "pregnancy",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Pregnancy Testing",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.5-pregnancy-testing",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.text",
"condition": [ "cmp-1" ],
"comment": "Optional section to specify pregnancy testing requirements.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:pregnancy.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:pregnancy.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "suicidal",
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Suicidal Ideation and Behaviour Risk Monitoring",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.3.6-suicidal-ideation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.text",
"condition": [ "cmp-1" ],
"comment": "If the trial meets any of the criteria requiring suicidal ideation and behaviour risk monitoring by the guidance/guideline in each region, include justification for the need for suicidal ideation and behaviour risk monitoring in the study and add any specific instructions for the collection and interpretation of the assessment. In case this is an AESI in the study, justification will also need to be provided in the appropriate subsection of Section 9.4.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:safety.section:suicidal.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:safety.section:suicidal.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "pharmacokinetics",
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Pharmacokinetics",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.4-pharmacokinetics",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection and assay of samples and interpretation of PK assessments. If pharmacokinetic testing is not included in the study, state Not Applicable. •\tDescribe the biological sample(s) collected, the handling of samples, and the assay method. o\tSpecific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. •\tDescribe the retention time for the samples (ensuring alignment with the ICF). •\tIndicate the types of analyses that may be studied for each sample.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:pharmacokinetics.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:pharmacokinetics.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "genetics",
"max": "1",
"id": "Composition.section:assessments.section:genetics",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:genetics.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:genetics.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:genetics.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Genetic Testing",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:genetics.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:genetics.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:genetics.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:genetics.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:genetics.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.5-genetic-testing",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:genetics.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:genetics.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:genetics.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:genetics.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection and assay of samples for genetic analysis. If genetic testing is not included in the study, state Not Applicable. •\tDescribe the biological samples that will be collected (for example, tissue, serum, plasma, etc.), handling of samples, and the assay method. o\tSpecific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. •\tDescribe the retention time for the samples (ensuring alignment with the ICF). •\tIndicate the types of analyses that may be studied for each sample.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:genetics.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:genetics.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:genetics.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:genetics.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "biomarkers",
"max": "1",
"id": "Composition.section:assessments.section:biomarkers",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Biomarkers",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.6-biomarkers",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection of samples and assessment of biomarkers, including pharmacodynamics. If biomarker or pharmacodynamic testing is not included in the study, state Not Applicable. •\tDescribe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o\tSpecific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. •\tDescribe the retention time for the samples (ensuring alignment with the ICF). •\tIndicate the types of biomarkers that will be studied for each sample. •\tSpecify whether each sample is optional or required. Required samples must be based on a protocol objective.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:biomarkers.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:biomarkers.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "immunogenicity",
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Immunogenicity Assessments",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.7-immunogenicity-assessments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.text",
"condition": [ "cmp-1" ],
"comment": "Include any specific instructions for the collection of samples and interpretation of immunogenicity. If immunogenicity assessments are included within Efficacy Assessments or Safety Assessments, cross-reference to that section. If immunogenicity testing is not included in the study, state Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:immunogenicity.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:immunogenicity.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "economics",
"max": "1",
"id": "Composition.section:assessments.section:economics",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:economics.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:economics.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:assessments.section:economics.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Medical Resource Utilisation and Health Economics",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:assessments.section:economics.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:assessments.section:economics.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:assessments.section:economics.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:assessments.section:economics.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:assessments.section:economics.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section8.8-economics",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:assessments.section:economics.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:economics.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:economics.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:assessments.section:economics.text",
"condition": [ "cmp-1" ],
"comment": "This section does not apply to COAs. Include this section only for any value evidence and outcomes assessments not included in either the efficacy or safety sections. If medical resource utilization and health economics assessment is not included in the study, state Not Applicable. Describe the health outcome measures, collection method (for example, diary, physician interview), and participant burden.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:assessments.section:economics.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:economics.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:assessments.section:economics.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:assessments.section:economics.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "adverseEvents",
"max": "1",
"id": "Composition.section:adverseEvents",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Adverse Events, Serious Adverse Events, and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:adverseEvents.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9-adverse-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 5,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "definitions",
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Definitions",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.1-definitions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 2,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "adverseEventsDefinitions",
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Definitions of Adverse Events",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.1.1-definitions-adverse-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.text",
"condition": [ "cmp-1" ],
"comment": "Specify the AE definitions, including: •\tAny relevant regional AE requirements. •\tAny events that meet and do not meet the AE definition. •\tAny trial-specific AE clarifications. •\tThe trial-specific definition for an overdose. •\tIf applicable, any clarifications on the AE and SAE definitions for efficacy trials (for example, lack of efficacy or failure of pharmacological actions reporting).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "seriousAdverseEventsDefinitions",
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Definitions of Serious Adverse Events",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.1.2-definitions-serious-adverse-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.text",
"condition": [ "cmp-1" ],
"comment": "Specify the SAE definitions, including: •\tAny relevant regional SAE requirements. •\tAny events that meet and do not meet the SAE definition. •\tAny trial-specific SAE clarifications.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "productComplaintsDefinitions",
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Definitions of Medical Device Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.1.3-definitions-product-complaints",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.text",
"condition": [ "cmp-1" ],
"comment": "Specify the definitions of medical device product complaints.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "collectionMethods",
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.2-collection-methods",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.text",
"condition": [ "cmp-1" ],
"comment": "Specify the starting and ending time periods for and frequency of collecting AEs and SAEs. Cross refer to the Schedule of Assessments as appropriate.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:collectionMethods.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:collectionMethods.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "recording",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3-recording-and-follow-up",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 5,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "identifying",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Identifying AEs, SAEs and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3.1-identifying-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.text",
"condition": [ "cmp-1" ],
"comment": "Specify how AEs and SAEs will be identified (for example, spontaneous reporting, solicited questions).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:identifying.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "intensity",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Intensity",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3.2-intensity",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.text",
"condition": [ "cmp-1" ],
"comment": "Specify the intensity rating categories/scale.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:intensity.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "causality",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Causality",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3.3-causality",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.text",
"condition": [ "cmp-1" ],
"comment": "Specify: •\tThe causality categories/scale. •\tProcedures for assessing causality.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:causality.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:causality.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "recordingEvents",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Recording of AEs, SAEs, Pregnancy and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3.4-recording-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.text",
"condition": [ "cmp-1" ],
"comment": "Specify the Investigator's actions for recording AEs and SAEs, including severity, causality, and the final outcome.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "followup",
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Follow-up",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.3.5-followup",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.text",
"condition": [ "cmp-1" ],
"comment": "Specify the procedures for follow-up of AEs, SAEs, pregnancy and product complaints. Include the assessment tools that will be used to monitor the events and the duration of follow-up after appearance of the events. Specify any procedures to be used for trials in which death is not an endpoint.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:recording.section:followup.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:recording.section:followup.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "reporting",
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Reporting of AEs, SAEs, Pregnancy, and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.4-reporting-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "reportingSAEs",
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Reporting of SAEs",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.4.1-reporting-serious-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.text",
"condition": [ "cmp-1" ],
"comment": "Specify the SAE reporting method (for example, an electronic data collection tool or a paper CRF) and reporting timeline to the Sponsor.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "regulatoryRequirements",
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Regulatory Reporting Requirements for SAEs and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.4.2-regulatory-requirements",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.text",
"condition": [ "cmp-1" ],
"comment": "Specify: •\tThe investigators’ responsibilities for reporting SAEs and Medical Device Product Complaints to the Sponsor (and to Ethics Committees, where required), specifying timing of reporting to allow the Sponsor to meet their responsibilities •\tThe Sponsor’s legal/regulatory responsibilities to report SAEs to regulatory authorities, ethics committees, and investigators •\tSerious and unexpected adverse reaction reporting",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "specialInterest",
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Adverse Events of Special Interest",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.4.3-special-interest",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.text",
"condition": [ "cmp-1" ],
"comment": "Specify any Adverse Events of Special Interest (AESI): •\tOther events that merit reporting to the Sponsor, trial leadership, IRB, and regulatory agencies (for example, secondary malignancies in oncology trials). •\tOther reportable events not already included in the previous sections, such as cardiovascular events, medical device incidents (including malfunctions), laboratory test abnormalities, and trial intervention overdose. Include the following for each AESI: •\tThe definition of the event. Specify the MedDRA preferred terms to use to report the AESI. •\tIf it is a measurable quantity, specify how will the measurement be done. •\tIf it is a clinical event, specify how will it be confirmed.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "diseaseRelatedEvents",
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Disease-related Events or Outcomes Not Qualifying as AEs or SAEs",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.4.4-disease-related-events",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.text",
"condition": [ "cmp-1" ],
"comment": "Specify any Disease-Related Events (DREs), disease-related outcomes (DROs), or both that will not be reported as AEs or SAEs (for example, seizures in anticonvulsant trials) or state not applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "pregnancy",
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.5-collection-methods",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "pregnant",
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Participants Who Become Pregnant During the Trial",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.5.1-pregnant",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.text",
"condition": [ "cmp-1" ],
"comment": "See Template for instructions.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "pregnantPartner",
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Participants Whose Partners Become Pregnant",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section9.5.2-pregnant-partner",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.text",
"condition": [ "cmp-1" ],
"comment": "See Template for instructions.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "statistics",
"max": "1",
"id": "Composition.section:statistics",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Statistical Considerations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:statistics.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10-statistics",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.text",
"condition": [ "cmp-1" ],
"comment": "Ensure that the data analysis complies with ICH E9 Guideline and ICH E9(R1) Guideline. In general, all relevant data collected in the trial should be considered in this statistical considerations section. Provide a statement with regard to when the primary analyses will be conducted. For example: The analysis will be conducted on all participant data at the time the trial ends.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "analysisSets",
"max": "1",
"id": "Composition.section:statistics.section:analysisSets",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Analysis Sets",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.1-analysis-sets",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.text",
"condition": [ "cmp-1" ],
"comment": "Analysis sets to support each analysis will be specified here and described in the Statistical Analysis Plan.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisSets.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisSets.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "analysisPrimaryObjective",
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Analysis Supporting Primary Objective",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2-analysis-primary-objective",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.text",
"condition": [ "cmp-1" ],
"comment": "This section introduces the Statistical Analysis Plan, with the detail to be provided in the subsequent subsections. This includes describing the methods of estimation (analytic approach) in alignment with how the estimands are defined. Sensitivity analyses should be aligned with how the estimands and estimators are defined.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "statisticalModel",
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Statistical Model, Hypothesis, and Method of Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2.1-statistical-model",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.text",
"condition": [ "cmp-1" ],
"comment": "Ensure that the statistical hypothesis/model (and corresponding assumptions)/analysis is aligned with the primary estimand(s). For all applicable objectives (for example, primary, secondary), under the appropriate header, state the null and alternative hypotheses, including the pre-planned type 1 error, or alternative criteria to define trial success and relevant operating characteristics if appropriate. Describe the statistical model used and the factors that will be included (covariates and interactions) and any rules for handling these factors (for example, pooling of centres). If applicable, state and describe any adjustments to account for multiplicity. If modelling and simulation methods are to be used, please describe the model (inputs and outputs), the underlying assumptions, and the method of model fitting.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "intercurrentEventHandling",
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Intercurrent Events of Primary Estimand",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2.2-intercurrent-events-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.text",
"condition": [ "cmp-1" ],
"comment": "For each intercurrent event of the primary estimand(s) (Section 3.1, Estimand[s] for the Primary Objective[s]), explain how data will be handled for the statistical analysis in line with the primary estimand. The handling of intercurrent events in statistical analysis should be aligned with the specific estimand strategies being used. This section should describe with more detail the rationale and handling of the data rather than repeating the guidance from the preceding sections.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "missingData",
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Missing Data",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2.3-missing-data-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.text",
"condition": [ "cmp-1" ],
"comment": "This section should describe how missing data will be dealt with. Refer to the E9(R1) addendum when estimand framework is used. The protocol should describe how missing data will be handled (for example, type of imputation technique, if any, and provide justification). In cases where the Primary Objective is related to safety, this section should also be completed. It may also be helpful to include additional statements regarding handling of missing data in general for other important efficacy or safety endpoints or this information can be included in the analysis of secondary endpoint section below.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sensitvityAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Sensitivity Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2.4-sensitivity-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Sensitivity analyses are a series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying modelling assumptions and limitations in the data.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "supplementaryAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Supplementary Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.2.5-supplementary-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Describe any supplementary analysis if applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "secondaryAnalysis",
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Analysis Supporting Secondary Objective",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3-analysis-secondary-objective",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "This section introduces the Statistical Analysis Plan, with the detail to be provided in the subsequent subsections. This includes describing the methods of estimation (analytic approach) in alignment with how the estimands are defined. Sensitivity analyses should be aligned with how the estimands and estimators are defined.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "statisticalModel",
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Statistical Model, Hypothesis, and Method of Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3.1-statistical-model",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.text",
"condition": [ "cmp-1" ],
"comment": "Ensure that the statistical hypothesis/model (and corresponding assumptions)/analysis is aligned with the primary estimand(s). For all applicable objectives (for example, primary, secondary), under the appropriate header, state the null and alternative hypotheses, including the pre-planned type 1 error, or alternative criteria to define trial success and relevant operating characteristics if appropriate. Describe the statistical model used and the factors that will be included (covariates and interactions) and any rules for handling these factors (for example, pooling of centres). If applicable, state and describe any adjustments to account for multiplicity. If modelling and simulation methods are to be used, please describe the model (inputs and outputs), the underlying assumptions, and the method of model fitting.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "intercurrentEventHandling",
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Intercurrent Events of Secondary Estimand",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3.2-intercurrent-events-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.text",
"condition": [ "cmp-1" ],
"comment": "For each intercurrent event of the secondary estimand(s), explain how data will be handled for the statistical analysis in line with the secondary estimand. The handling of intercurrent events in statistical analysis should be aligned with the specific estimand strategies being used. This section should describe with more detail the rationale and handling of the data rather than repeating the guidance from the preceding sections.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:intercurrentEventHandling.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "missingData",
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Missing Data",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3.3-missing-data-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.text",
"condition": [ "cmp-1" ],
"comment": "This section should describe how missing data will be dealt with. Refer to the E9(R1) addendum when estimand framework is used. The protocol should describe how missing data will be handled (for example, type of imputation technique, if any, and provide justification).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:missingData.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sensitvityAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Sensitivity Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3.4-sensitivity-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Sensitivity analyses are a series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying modelling assumptions and limitations in the data.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:sensitvityAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "supplementaryAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Supplementary Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.3.5-supplementary-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Describe any supplementary analysis if applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:secondaryAnalysis.section:supplementaryAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "exploratoryAnalysis",
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Analysis of Exploratory Objective",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4-analysis-exploratory-objective",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "This section introduces the Statistical Analysis Plan, with the detail to be provided in the subsequent subsections. This includes describing the methods of estimation (analytic approach) in alignment with how the estimands are defined. Sensitivity analyses should be aligned with how the estimands and estimators are defined.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "statisticalModel",
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Statistical Model, Hypothesis, and Method of Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4.1-statistical-model",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.text",
"condition": [ "cmp-1" ],
"comment": "Ensure that the statistical hypothesis/model (and corresponding assumptions)/analysis is aligned with the primary estimand(s). For all applicable objectives (for example, primary, secondary), under the appropriate header, state the null and alternative hypotheses, including the pre-planned type 1 error, or alternative criteria to define trial success and relevant operating characteristics if appropriate. Describe the statistical model used and the factors that will be included (covariates and interactions) and any rules for handling these factors (for example, pooling of centres). If applicable, state and describe any adjustments to account for multiplicity. If modelling and simulation methods are to be used, please describe the model (inputs and outputs), the underlying assumptions, and the method of model fitting.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:statisticalModel.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "intercurrentEventHandling",
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Intercurrent Events of Exploratory Estimand",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4.2-intercurrent-events-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.text",
"condition": [ "cmp-1" ],
"comment": "For each intercurrent event of the exploratory estimand(s), explain how data will be handled for the statistical analysis in line with the exploratory estimand. The handling of intercurrent events in statistical analysis should be aligned with the specific estimand strategies being used. This section should describe with more detail the rationale and handling of the data rather than repeating the guidance from the preceding sections.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:intercurrentEventHandling.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "missingData",
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Handling of Missing Data",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4.3-missing-data-handling",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.text",
"condition": [ "cmp-1" ],
"comment": "This section should describe how missing data will be dealt with. Refer to the E9(R1) addendum when estimand framework is used. The protocol should describe how missing data will be handled (for example, type of imputation technique, if any, and provide justification).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:missingData.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sensitvityAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Sensitivity Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4.4-sensitivity-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Sensitivity analyses are a series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying modelling assumptions and limitations in the data.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:sensitvityAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "supplementaryAnalysis",
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Supplementary Analysis",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.4.5-supplementary-analysis",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.text",
"condition": [ "cmp-1" ],
"comment": "Describe any supplementary analysis if applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:exploratoryAnalysis.section:supplementaryAnalysis.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "safetyAnalyses",
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Safety Analyses",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.5-safety-analyses",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.text",
"condition": [ "cmp-1" ],
"comment": "If safety is a primary and/or secondary objective, describe the corresponding safety analyses in the appropriate section above (Section 10.2 or Section 10.3).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:safetyAnalyses.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:safetyAnalyses.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "otherAnalyses",
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Other Analyses",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.6-other-analyses",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.text",
"condition": [ "cmp-1" ],
"comment": "Describe Other Analyses such as Subgroup analyses, Adjusted analysis if needed.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:otherAnalyses.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:otherAnalyses.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "interimAnalyses",
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Interim Analyses",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.7-interim-analyses",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.text",
"condition": [ "cmp-1" ],
"comment": "Describe any interim analysis and criteria for stopping or adapting the trial. The description should include, but is not limited to, the following: {See Template for full list}",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:interimAnalyses.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:interimAnalyses.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sampleSize",
"max": "1",
"id": "Composition.section:statistics.section:sampleSize",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Sample Size Determination",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.8-sample-size-determination",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.text",
"condition": [ "cmp-1" ],
"comment": "This section should detail the methods used for the determination of the sample size and a reference to tables or statistical software used to carry out the calculation. Sufficient information should be provided so that the sample size calculation can be reproduced or described. If the planned sample size is not derived statistically, then this should be explicitly stated along with a rationale for the intended sample size (for example, exploratory nature of pilot trials; pragmatic considerations for trials in rare diseases).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:sampleSize.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:sampleSize.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "protocolDeviations",
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Protocol Deviations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section10.9-protocol-deviations",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.text",
"condition": [ "cmp-1" ],
"comment": "Plans for detecting, reviewing, and reporting any deviations from the protocol should be described.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:statistics.section:protocolDeviations.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:statistics.section:protocolDeviations.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "oversight",
"max": "1",
"id": "Composition.section:oversight",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "General Considerations: Regulatory, Ethical, and Trial Oversight",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:oversight.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11-oversight",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 6,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "regulatory",
"max": "1",
"id": "Composition.section:oversight.section:regulatory",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:regulatory.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:regulatory.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:regulatory.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Regulatory and Ethical Considerations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:regulatory.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:regulatory.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:regulatory.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:regulatory.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:regulatory.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.1-regulatory-considerations",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:regulatory.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:regulatory.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:regulatory.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:regulatory.text",
"condition": [ "cmp-1" ],
"comment": "List the prevailing ethical, legal, and regulatory guidelines that will be applied throughout the trial.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:regulatory.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:regulatory.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:regulatory.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:regulatory.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "trialOversight",
"max": "1",
"id": "Composition.section:oversight.section:trialOversight",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Trial Oversight",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.2-trial-oversight",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.text",
"condition": [ "cmp-1" ],
"comment": "Describe the trial oversight listing the investigator and sponsor responsibilities not covered in other sections of the protocol which are essential for the operations of the trial, specifying the ones related to quality assurance.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 2,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "investigatorResponsibilities",
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Investigator Responsibilities",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.2.1-investigator-responsibilities",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sponsorResponsibilities",
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Sponsor Responsibilities",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.2.2-sponsor-responsibilities",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.text",
"condition": [ "cmp-1" ],
"comment": "Describe the sponsor duties to be delegated to a third party that may impact the investigators sites, if applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "committees",
"max": "1",
"id": "Composition.section:oversight.section:committees",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:committees.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:committees.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:committees.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Committees",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:committees.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:committees.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:committees.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:committees.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:committees.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.3-committees",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:committees.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:committees.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:committees.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:committees.text",
"condition": [ "cmp-1" ],
"comment": "Briefly describe the administrative structure of committees that will be reviewing data while the trial is ongoing, and the type of committee (for example, Dose Escalation Committee, Data Monitoring Committee or Data Safety Monitoring Board). Note that specific details may be required depending on local law or regulation. If applicable, Committee Charters may be cross-referenced. If no committees are applicable, state Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:committees.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:committees.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:committees.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:committees.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "informedConsent",
"max": "1",
"id": "Composition.section:oversight.section:informedConsent",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Informed Consent Process",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.4-informed-consent-process",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.text",
"condition": [ "cmp-1" ],
"comment": "Specify the key elements of the informed consent process, including any special needs and how these are addressed (for example, assent, capacity, legally acceptable representative, adolescents who may reach age of majority during the trial, pregnant participants and pregnant partners of participants).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "assentProcess",
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Assent Process",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.4.0-assent-process",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "emergency",
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Emergency Consent Process",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.4.0-emergency-consent-process",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.text",
"condition": [ "cmp-1" ],
"comment": "If enrollment in the trial may occur during an emergency in which the participant or their legally acceptable representative is not able or available to give consent, describe the consent process.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:emergency.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "rescreening",
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Informed Consent for Rescreening",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.4.1-rescreening-consent-process",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.text",
"condition": [ "cmp-1" ],
"comment": "If participants can be rescreened, add the text to state whether the participant needs to complete a new consent. Screen failure and rescreening should be clearly defined in the protocol, with cross-reference to those definitions.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "remainingSamples",
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Informed Consent for Remaining Samples in Exploratory Research",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.4.2-remaining-samples",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.text",
"condition": [ "cmp-1" ],
"comment": "If any exploratory research is planned and additional written consent regarding the use of remaining samples for exploratory research will be obtained, describe the consent process.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "insurance",
"max": "1",
"id": "Composition.section:oversight.section:insurance",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:insurance.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:insurance.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:insurance.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Insurance and Indemnity",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:insurance.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:insurance.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:insurance.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:insurance.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:insurance.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.5-insurance-and-indemnity",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:insurance.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:insurance.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:insurance.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:insurance.text",
"condition": [ "cmp-1" ],
"comment": "Describe the arrangements for participants insurance and indemnity if not addressed in a separate agreement.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:insurance.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:insurance.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:insurance.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:insurance.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "earlySiteClosure",
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Early Site Closure",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.6-early-site-closure",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "decisionRights",
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Decision Rights for Site Closure",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.6-early-site-closure#decisionRights",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.text",
"condition": [ "cmp-1" ],
"comment": "List the sponsor's rights to close a site. Likewise, list the investigator's rights to initiate early site closure.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:decisionRights.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "criteria",
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Crteria for Early Closure",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.6-early-site-closure#criteria",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.text",
"condition": [ "cmp-1" ],
"comment": "List the criteria for early closure of a site by the sponsor or investigator.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "responsibilities",
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Responsibilities Following Early Site Closure",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section11.6-early-site-closure#responsibilities",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.text",
"condition": [ "cmp-1" ],
"comment": "List the responsibilities of the sponsor and investigator following early site closure, such as informing the ethics committee(s), and prompt notification of the participant and transition to appropriate therapy and/or follow-up.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "riskManagementAndData",
"max": "1",
"id": "Composition.section:riskManagementAndData",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "General Considerations: Risk Management and Data Governance",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:riskManagementAndData.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:riskManagementAndData.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section12-risk-management-and-data-governance",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:riskManagementAndData.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 3,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "riskManagement",
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Risk Management",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section12.1-risk-management",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.text",
"condition": [ "cmp-1" ],
"comment": "Describe how the critical to quality factors will be mitigated. It is important to determine the risks that threaten their integrity and decide whether they can be accepted or should be mitigated, based on their probability, detectability and impact. Where it is decided that risks should be mitigated, the necessary control processes should be put in place and communicated, and the necessary actions taken to mitigate the risks.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:riskManagement.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:riskManagement.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "dataGovernance",
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Data Governance",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section12.2-data-governance",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.text",
"condition": [ "cmp-1" ],
"comment": "Describe the key processes for critical trial integrity, traceability and security enabling accurate collection, reporting, monitoring, transfer, retention, access and publication if not addressed in separate agreement(s). Describe the measures to protect the privacy and confidentiality of personal information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:dataGovernance.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "sourceData",
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Source Data",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section12.3-source-data",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.text",
"condition": [ "cmp-1" ],
"comment": "Establish the importance of source data and expectation for traceability of transcribed information back to source. Delineate expectations for investigators (for example, maintain source data at the site, ensure availability of current records) and trial monitors (for example, verify CRF data relative to source, safety of participants is being protected, conduct is in accordance with GCP). Define what constitutes source data and its origin or provide a reference to the location of these definitions, if contained in a separate document, such as a monitoring guideline or source data acknowledgement). Describe the provision for direct access to source data and documents enabling clinical trial-related monitoring, audits and regulatory inspections, if not included in separate agreement(s).",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:riskManagementAndData.section:sourceData.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:riskManagementAndData.section:sourceData.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "definitions",
"max": "1",
"id": "Composition.section:definitions",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Appendix: Definitions and Supporting Operational Details",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:definitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13-definitions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 4,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "contraception",
"max": "1",
"id": "Composition.section:definitions.section:contraception",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Contraception",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.1-contraception",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 0,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.text",
"condition": [ "cmp-1" ],
"comment": "Document profiles may define what content should be represented in the narrative to ensure clinical safety.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 2,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
},
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "contraceptionDefinitions",
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Definitions Related to Childbearing Potential",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.1.1-contraception-definitions",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.text",
"condition": [ "cmp-1" ],
"comment": "Specify the definitions of Participant of childbearing potential and Participant of non-childbearing potential, or state Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "contraceptionDetails",
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Contraception",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.1.2-contraception-details",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.text",
"condition": [ "cmp-1" ],
"comment": "Specify the contraceptive methods required and duration of use, or state Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "clinicalLaboratoryTests",
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Clinical Laboratory Tests",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.2-clinical-laboratory-tests",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.text",
"condition": [ "cmp-1" ],
"comment": "Specify which laboratory parameters should be included in each clinical laboratory assessment panel (for example, for haematology, chemistry, urinalysis). A tabular presentation for such information is common. If applicable, include equations and references for locally calculated laboratory results. If not applicable, retain header and enter Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "regional",
"max": "1",
"id": "Composition.section:definitions.section:regional",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:regional.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:regional.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:regional.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Country/Region-Specific Differences",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:regional.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:regional.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:regional.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:regional.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:regional.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.3-country-specific-differences",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:regional.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:regional.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:regional.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:regional.text",
"condition": [ "cmp-1" ],
"comment": "Although global clinical trial practices are increasingly harmonised, some country/ region-specific differences in requirements do exist (for example, document retention periods, contraception requirements). Where differences in requirements cannot be reconciled, sponsors should explain how they will document and communicate country/region-specific differences (for example, by country/region-specific amendments or addenda). An alternative to country/region-specific amendments is to list the specific differences by country or countries in this section, including a reference to the relevant section of the protocol where the differing requirement applies. If not applicable, retain header and enter Not Applicable.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:regional.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:regional.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:regional.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:regional.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 1,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "priorAmendments",
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"path": "Composition.section.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Prior Protocol Amendment(s)",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/doc-section-codes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "CompositionSectionType"
} ],
"description": "Classification of a section of a composition/document."
},
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section13.4-prior-protocol-amendments",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.text",
"condition": [ "cmp-1" ],
"comment": "Either enter value of {Not applicable. The protocol has not been amended.} or {Not applicable. This is the first protocol amendment.} or SEE TEMPLATE INSTRUCTIONS.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:definitions.section:priorAmendments.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:definitions.section:priorAmendments.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "glossary",
"max": "1",
"id": "Composition.section:glossary",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:glossary.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:glossary.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:glossary.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Appendix: Glossary of Terms and Abbreviations",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:glossary.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:glossary.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:glossary.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:glossary.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:glossary.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section14-glossary",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:glossary.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:glossary.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:glossary.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:glossary.text",
"condition": [ "cmp-1" ],
"comment": "Define abbreviations and other terms used in the protocol. A tabular presentation is common and may serve as the definition at first use.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:glossary.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ValueSet", "http://hl7.org/fhir/StructureDefinition/CodeSystem" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:glossary.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:glossary.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:glossary.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
}, {
"constraint": [ {
"key": "cmp-1",
"human": "A section must contain at least one of text, entries, or sub-sections",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "text.exists() or entry.exists() or section.exists()"
}, {
"key": "cmp-2",
"human": "A section can only have an emptyReason if it is empty",
"source": "http://hl7.org/fhir/StructureDefinition/Composition",
"severity": "error",
"expression": "emptyReason.empty() or entry.empty()"
}, {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section",
"min": 1,
"definition": "The root of the sections that make up the composition.",
"isModifier": false,
"short": "Composition is broken into sections",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.structuredBody.component.section",
"identity": "cda"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"sliceName": "references",
"max": "1",
"id": "Composition.section:references",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section"
},
"isSummary": false
}, {
"path": "Composition.section.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:references.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:references.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Composition.section:references.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.title",
"requirements": "Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.",
"min": 0,
"definition": "The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.",
"isModifier": false,
"short": "Label for section (e.g. for ToC)",
"mapping": [ {
"map": "./title",
"identity": "rim"
}, {
"map": ".title",
"identity": "cda"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"patternString": "Appendix: References",
"alias": [ "header", "label", "caption" ],
"max": "1",
"id": "Composition.section:references.title",
"comment": "The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.title"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code",
"requirements": "Provides computable standardized labels to topics within the document.",
"min": 0,
"definition": "A code identifying the kind of content contained within the section. This must be consistent with the section title.",
"isModifier": false,
"short": "Classification of section (recommended)",
"mapping": [ {
"map": "./code",
"identity": "rim"
}, {
"map": ".code",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "https://fevir.net/resources/ValueSet/179431"
},
"max": "1",
"id": "Composition.section:references.code",
"comment": "The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. \n\nIf the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.code"
},
"isSummary": false
}, {
"path": "Composition.section.code.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Composition.section:references.code.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Composition.section.code.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Composition.section:references.code.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "Composition.section:references.code.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.code.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"patternString": "section15-references",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "Composition.section:references.code.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.author",
"requirements": "Identifies who is responsible for the content.",
"min": 0,
"definition": "Identifies who is responsible for the information in this section, not necessarily who typed it in.",
"isModifier": false,
"short": "Who and/or what authored the section",
"mapping": [ {
"map": "FiveWs.author",
"identity": "w5"
}, {
"map": ".participation[typeCode=\"AUT\"].role[classCode=\"ASSIGNED\"]",
"identity": "rim"
}, {
"map": ".author.assignedAuthor",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson", "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:references.author",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.author"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.focus",
"min": 0,
"definition": "The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).",
"isModifier": false,
"short": "Who/what the section is about, when it is not about the subject of composition",
"mapping": [ {
"map": ".subject? (CDA did not differentiate between subject and focus)",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Resource" ]
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:references.focus",
"comment": "Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.focus"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.text",
"min": 1,
"definition": "A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative.",
"isModifier": false,
"short": "Text summary of the section, for human interpretation",
"mapping": [ {
"map": ".text",
"identity": "rim"
}, {
"map": ".text",
"identity": "cda"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"max": "1",
"id": "Composition.section:references.text",
"condition": [ "cmp-1" ],
"comment": "References should be listed in a common format that includes all relevant information to identify the source and date published. If not published, this should be clearly indicated.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.text"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.orderedBy",
"requirements": "Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.",
"min": 0,
"definition": "Specifies the order applied to the items in the section entries.",
"isModifier": false,
"short": "Order of section entries",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP].sequenceNumber > 1",
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-order",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEntryOrder"
} ],
"description": "What order applies to the items in the entry."
},
"max": "1",
"id": "Composition.section:references.orderedBy",
"comment": "Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.orderedBy"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.entry",
"min": 0,
"definition": "A reference to the actual resource from which the narrative in the section is derived.",
"isModifier": false,
"short": "A reference to data that supports this section",
"mapping": [ {
"map": ".outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]",
"identity": "rim"
}, {
"map": ".entry",
"identity": "cda"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Citation" ]
} ],
"mustSupport": false,
"max": "*",
"id": "Composition.section:references.entry",
"condition": [ "cmp-1", "cmp-2" ],
"comment": "If there are no entries in the list, an emptyReason SHOULD be provided.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.entry"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.emptyReason",
"requirements": "Allows capturing things like \"none exist\" or \"not asked\" which can be important for most lists.",
"min": 0,
"definition": "If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.",
"isModifier": false,
"short": "Why the section is empty",
"mapping": [ {
"map": ".inboundRelationship[typeCode=SUBJ,code,
"identity": "rim"
}, {
"map": "n/a",
"identity": "cda"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/list-empty-reason",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SectionEmptyReason"
} ],
"description": "If a section is empty, why it is empty."
},
"max": "1",
"id": "Composition.section:references.emptyReason",
"condition": [ "cmp-2" ],
"comment": "The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.",
"base": {
"max": "1",
"min": 0,
"path": "Composition.section.emptyReason"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Composition.section.section",
"min": 0,
"definition": "A nested sub-section within this section.",
"isModifier": false,
"short": "Nested Section",
"mapping": [ {
"map": "./outboundRelationship[typeCode=\"COMP\" and isNormalActRelationship()]/target[moodCode=\"EVN\" and classCode=\"DOCSECT\" and isNormalAct]",
"identity": "rim"
}, {
"map": ".component.section",
"identity": "cda"
} ],
"contentReference": "http://hl7.org/fhir/StructureDefinition/Composition#Composition.section",
"mustSupport": false,
"max": "*",
"id": "Composition.section:references.section",
"comment": "Nested sections are primarily used to help human readers navigate to particular portions of the document.",
"base": {
"max": "*",
"min": 0,
"path": "Composition.section.section"
},
"isSummary": false
} ]
},
"status": "draft",
"id": "9aa09ee2-ae5f-4c44-8792-1f2891eefe67",
"kind": "resource",
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report",
"version": "1.0.0-ballot",
"differential": {
"element": [ {
"id": "Composition",
"path": "Composition"
}, {
"id": "Composition.category",
"min": 1,
"path": "Composition.category",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "text",
"type": "value"
} ]
}
}, {
"id": "Composition.category:m11report",
"max": "1",
"min": 1,
"path": "Composition.category",
"sliceName": "m11report",
"mustSupport": true
}, {
"id": "Composition.category:m11report.text",
"min": 1,
"path": "Composition.category.text",
"patternString": "CeSHarP Report"
}, {
"id": "Composition.section",
"min": 15,
"path": "Composition.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
}
}, {
"id": "Composition.section:summary",
"max": "1",
"min": 1,
"path": "Composition.section",
"sliceName": "summary",
"mustSupport": true
}, {
"id": "Composition.section:summary.title",
"path": "Composition.section.title",
"patternString": "Protocol Summary"
}, {
"id": "Composition.section:summary.code.text",
"min": 1,
"path": "Composition.section.code.text",
"patternString": "section1-protocol-summary"
}, {
"id": "Composition.section:summary.section",
"min": 3,
"path": "Composition.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
}
}, {
"id": "Composition.section:summary.section:protocolSynopsis",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "protocolSynopsis",
"mustSupport": true
}, {
"id": "Composition.section:summary.section:protocolSynopsis.title",
"path": "Composition.section.section.title",
"patternString": "Protocol Synopsis"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section1.1-protocol-synopsis"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section",
"min": 6,
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
}
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "objectivesEndpoints",
"mustSupport": true
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.title",
"path": "Composition.section.section.section.title",
"patternString": "Primary and Secondary Objectives and Endpoints"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "section1.1.1-objectives-endpoints"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Include a copy of the Objectives/Endpoints Table including primary and secondary endpoints only from Section 3 of the protocol and follow all the same instructions. Not all trials will have a complete estimand. Do not include exploratory endpoints in the synopsis."
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.entry",
"path": "Composition.section.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Composition" ]
} ]
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "overallDesign"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.title",
"path": "Composition.section.section.section.title",
"patternString": "Overall Design"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "section1.1.2-overall-design"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "see Template instructions"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:overallDesign.entry",
"path": "Composition.section.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Composition", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ]
} ]
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "numberOfArms"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "Number of Arms"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfArms.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Enter the numeric value for the number of arms in the trial. For trials with a different number of arms in different periods, populate this field based on the total number of arms."
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "blinding"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "Blinding"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:blinding.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "For designs in which these details may differ in one or more trial periods, answer according to the portion of the trial in which the highest number of blinded roles occurs. More details can be provided in Section 6.6 of the protocol. Blinded roles: The following roles indicated will not be made aware of the treatment group assignment during the trial: [blinded roles] Not applicable (No blinding) indicates an open-label trial."
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "numberOfParticipants"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.code.text",
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"path": "Composition.section.section.section.code.text",
"patternString": "Number of Participants"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "State the expected number of participants to be assigned to trial intervention/enrolled. Indicate whether the number provided is the target or maximum number of individuals to be randomly assigned to trial intervention/enrolled. A [Target/ Maximum] of [[Enter Number of Participants]] participants will be [randomly assigned to trial intervention/ enrolled]."
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:duration",
"max": "1",
"min": 0,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "duration"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "Arms and Duration"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:duration.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "See Template instructions."
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:committees",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "committees"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "Committees"
}, {
"id": "Composition.section:summary.section:protocolSynopsis.section:committees.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Indicate whether any committee(s) will be reviewing data while the trial is ongoing, and the type of committee. Common examples include Data Monitoring Committee, Dose Escalation Committee, or Endpoint Adjudication Committee; describe others, if applicable. List independent committees in the space indicated. Other committees may be included at the Sponsor’s discretion in the separate space provided. Committees listed here should be fully described in Section 11.3. Indicate N/A if no independent committees will be involved in the trial. Delete Other Committees if not applicable."
}, {
"id": "Composition.section:summary.section:trialSchema",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
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} ],
"sliceName": "trialSchema",
"mustSupport": true
}, {
"id": "Composition.section:summary.section:trialSchema.title",
"path": "Composition.section.section.title",
"patternString": "Trial Schema"
}, {
"id": "Composition.section:summary.section:trialSchema.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section1.2-trial-schema"
}, {
"id": "Composition.section:summary.section:trialSchema.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "The purpose of this section is to provide a visual depiction of the trial design, orienting users of the protocol to the key features of the design. The schema depicts the trial arms, the flow of individual participants through the progression of trial period(s)/epochs (such as screening, washout/run-in, intervention, and key milestones [for example, randomisation, cross-over, end of treatment]). For complex trials, additional schemas may be added to describe activities or trial periods in greater detail."
}, {
"id": "Composition.section:summary.section:trialSchema.entry",
"path": "Composition.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition" ]
} ]
}, {
"id": "Composition.section:summary.section:scheduleOfActivities",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
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} ],
"sliceName": "scheduleOfActivities",
"mustSupport": true
}, {
"id": "Composition.section:summary.section:scheduleOfActivities.title",
"path": "Composition.section.section.title",
"patternString": "Schedule of Activities"
}, {
"id": "Composition.section:summary.section:scheduleOfActivities.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section1.3-schedule-of-activities"
}, {
"id": "Composition.section:summary.section:scheduleOfActivities.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "The schedule of activities must capture the procedures that will be accomplished at each trial visit, and all contact with participants, for example, telephone contacts. This includes any tests that are used for eligibility, participant randomisation or stratification, or decisions on trial intervention discontinuation. Allowable windows should be stated for all visits and procedures. A tabular format is recommended."
}, {
"id": "Composition.section:summary.section:scheduleOfActivities.entry",
"path": "Composition.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition" ]
} ]
}, {
"id": "Composition.section:introduction",
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"min": 1,
"path": "Composition.section",
"sliceName": "introduction",
"mustSupport": true
}, {
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"path": "Composition.section.title",
"patternString": "Introduction"
}, {
"id": "Composition.section:introduction.code.text",
"min": 1,
"path": "Composition.section.code.text",
"patternString": "section2-introduction"
}, {
"id": "Composition.section:introduction.section",
"min": 2,
"path": "Composition.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
}
}, {
"id": "Composition.section:introduction.section:purposeOfTrial",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
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} ],
"sliceName": "purposeOfTrial",
"mustSupport": true
}, {
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"patternString": "Purpose of Trial"
}, {
"id": "Composition.section:introduction.section:purposeOfTrial.code.text",
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"path": "Composition.section.section.code.text",
"patternString": "section2.1-trial-purpose"
}, {
"id": "Composition.section:introduction.section:purposeOfTrial.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Explain why the trial is needed, why the research questions being asked are important. Do not restate the IB."
}, {
"id": "Composition.section:introduction.section:benefitsAndRisks",
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"min": 1,
"path": "Composition.section.section",
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} ],
"sliceName": "benefitsAndRisks",
"mustSupport": true
}, {
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"patternString": "Summary of Benefits and Risks"
}, {
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"path": "Composition.section.section.code.text",
"patternString": "section2.2-benefits-risks"
}, {
"id": "Composition.section:introduction.section:benefitsAndRisks.section",
"min": 3,
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "code.text",
"type": "value"
} ]
}
}, {
"id": "Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary",
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} ],
"sliceName": "benefitSummary",
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"patternString": "Benefit Summary"
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"min": 1,
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"comment": "The benefit summary should be written from the perspective of an individual participant, and should describe any physical, psychological, social, legal, or any other potential benefits to individual participants as a result of participating in the trial, addressing immediate potential benefits and/or long-range potential benefits. Clearly state if no benefits to an individual participant can be anticipated, or if potential benefits are unknown. For early clinical trials such as Phase 1, benefits for an individual participant (other than those of altruism) are expected to be minimal. Benefits to society in general may also be included but should be described separately."
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}, {
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}, {
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"comment": "Provide a succinct, concluding statement on the perceived balance between risks that have been identified from cumulative safety data, protocol procedures, and anticipated efficacy/benefits within the context of the proposed trial. Risks need to be assessed against the benefits for the individual participant at least once a year."
}, {
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"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
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}, {
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Enter 'Primary' or 'Secondary' or 'Exploratory' as the data value."
}, {
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:objective",
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"min": 1,
"path": "Composition.section.section.section",
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Precisely define each clinical question of interest by stating each trial objective."
}, {
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Enter the description of the Endpoint (measured variable)."
}, {
"id": "Composition.section:endpoints.section:objectiveEndpoint.section:estimand",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the attributes that construct the estimand: the treatment condition of interest, the population of participants targeted by the clinical question of interest, other intercurrent events (if applicable), a population level summary, and the endpoint (or variable) specified in the table above."
}, {
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"comment": "If applicable, describe any stakeholder (for example, patient, healthcare professional and patient advocacy groups) involvement in the design of the trial and any suggestions implemented."
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"comment": "Provide a rationale for the trial intervention model selected in Section 4.1, Description of Trial Design with a cross-reference to Section 6.2, Rationale for Investigational Intervention(s). Rationale for choice of comparator, if applicable, should be described separately in Section 4.2.5, Rationale for Comparator. A rationale for the choice of trial population should be described separately in Section 5.1, Description of Trial Population and Rationale."
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}, {
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"comment": "Provide a rationale that the trial endpoint(s) described in Section 3, Trial Objectives, Endpoints, and Estimands, are clinically relevant and provide a reliable and valid measurement of the intended intervention effect."
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"comment": "If applicable, provide a rationale for any interim analysis planned with respect to its purpose (for example, stopping the trial early for efficacy or futility) and timing."
}, {
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"comment": "If applicable, provide a rationale for the type of control selected for the trial (for example, placebo, active drug, combination, historical). Describe any known or potential problems associated with the control group selected in light of the specific disease and intervention(s) being studied. If comparators will differ by region, describe."
}, {
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}, {
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"path": "Composition.section.section.section.text",
"comment": "Discuss rationale for any additional aspects of the design not addressed above."
}, {
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"path": "Composition.section.section",
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"comment": "If applicable, describe any trial-specific stopping rules, including guidance on when the trial should be stopped for safety reasons, when a cohort or dose escalation should be terminated, and/or when a given treatment arm should be terminated."
}, {
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}, {
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}, {
"id": "Composition.section:design.section:trialStoppingRules.section:temporaryHalt.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe when any of the stopping rules may result in a temporary halt of enrollment into the trial and criteria for restarting enrollment."
}, {
"id": "Composition.section:design.section:startEnd",
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"min": 1,
"path": "Composition.section.section",
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"sliceName": "startEnd",
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}, {
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}, {
"id": "Composition.section:design.section:startEnd.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Define key timepoints in the trial, including trial start and end dates. For example, a key timepoint definition for start of trial might be when the informed consent is signed by the first participant and a key timepoint definition for end of trial might be when participants are no longer being examined or the last participant’s last study assessment has occurred. If applicable, consider local regulatory requirements for these and other definitions (for example, the first act of recruitment). If appropriate, provide a cross-reference to Section 11.6"
}, {
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"min": 0,
"path": "Composition.section.section",
"type": [ {
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}, {
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}, {
"id": "Composition.section:design.section:access.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "If applicable, describe any possibilities for access to trial intervention, if any, beyond completion of the trial. Planned extension trials, if described above in Section 4.1 do not need to be repeated."
}, {
"id": "Composition.section:population",
"max": "1",
"min": 1,
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"sliceName": "population",
"mustSupport": true
}, {
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"min": 1,
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"patternString": "section5-trial-population"
}, {
"id": "Composition.section:population.section",
"min": 5,
"path": "Composition.section.section",
"slicing": {
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"discriminator": [ {
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}
}, {
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"sliceName": "description",
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}, {
"id": "Composition.section:population.section:description.title",
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}, {
"id": "Composition.section:population.section:description.text",
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"path": "Composition.section.section.text",
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}, {
"id": "Composition.section:population.section:description.entry",
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}, {
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"sliceName": "inclusionCriteria",
"mustSupport": true
}, {
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"path": "Composition.section.section.code.text",
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}, {
"id": "Composition.section:population.section:inclusionCriteria.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Inclusion criteria are characteristics that define the trial population, for example, those criteria that every potential participant must satisfy, to qualify for trial entry."
}, {
"id": "Composition.section:population.section:inclusionCriteria.entry",
"path": "Composition.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition" ]
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}, {
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"sliceName": "exclusionCriteria",
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}, {
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"path": "Composition.section.section.code.text",
"patternString": "section5.3-exclusion-criteria"
}, {
"id": "Composition.section:population.section:exclusionCriteria.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Exclusion criteria are characteristics that make an individual ineligible for participation."
}, {
"id": "Composition.section:population.section:exclusionCriteria.entry",
"path": "Composition.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition" ]
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}, {
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"min": 0,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "lifestyle",
"mustSupport": true
}, {
"id": "Composition.section:population.section:lifestyle.title",
"path": "Composition.section.section.title",
"patternString": "Lifestyle Restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section5.4-lifestyle-restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "In the following subsections, describe any restrictions during the trial pertaining to lifestyle and/or diet, intake of caffeine, alcohol, or tobacco, or physical and other activities. If not applicable, include a statement that no restrictions are required."
}, {
"id": "Composition.section:population.section:lifestyle.section",
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
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}
}, {
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"min": 0,
"path": "Composition.section.section.section",
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} ],
"sliceName": "dietary",
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}, {
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"patternString": "section5.4.1-dietary-restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.section:dietary.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe any restrictions on diet (for example, food and drink restrictions, timing of meals relative to dosing)."
}, {
"id": "Composition.section:population.section:lifestyle.section:substances",
"max": "1",
"min": 0,
"path": "Composition.section.section.section",
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"sliceName": "substances",
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}, {
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"patternString": "Caffeine, Alcohol, Tobacco, and Other Restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.section:substances.code.text",
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"path": "Composition.section.section.section.code.text",
"patternString": "section5.4.2-substances-restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.section:substances.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe any restrictions on the intake of caffeine, alcohol, tobacco, or other restrictions."
}, {
"id": "Composition.section:population.section:lifestyle.section:activity",
"max": "1",
"min": 0,
"path": "Composition.section.section.section",
"type": [ {
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"sliceName": "activity",
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}, {
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"path": "Composition.section.section.section.title",
"patternString": "Physical Activity Restrictions"
}, {
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"path": "Composition.section.section.section.code.text",
"patternString": "section5.4.3-activity-restrictions"
}, {
"id": "Composition.section:population.section:lifestyle.section:activity.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe any restrictions on activity (for example, in first-in-human trials, activity may be restricted by ensuring participants remain in bed for 4 to 6 hours after dosing)."
}, {
"id": "Composition.section:population.section:lifestyle.section:other",
"max": "1",
"min": 0,
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}, {
"id": "Composition.section:population.section:lifestyle.section:other.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe restrictions on any other activity (for example, blood or tissue donation); or any other activity restrictions, such as on driving, heavy machinery use, or sun exposure."
}, {
"id": "Composition.section:population.section:screenFailures",
"max": "1",
"min": 0,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "screenFailures",
"mustSupport": true
}, {
"id": "Composition.section:population.section:screenFailures.title",
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}, {
"id": "Composition.section:population.section:screenFailures.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Indicate how screen failure will be handled in the trial, including conditions and criteria upon which rescreening is acceptable. If applicable, indicate the circumstances and time window under which a repeat procedure is allowed for screen failure relating to specific inclusion/exclusion criteria for the trial."
}, {
"id": "Composition.section:intervention",
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"min": 1,
"path": "Composition.section",
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"mustSupport": true
}, {
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"min": 1,
"path": "Composition.section.code.text",
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"id": "Composition.section:intervention.section",
"min": 8,
"path": "Composition.section.section",
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}
}, {
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"id": "Composition.section:intervention.section:description.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "The investigational trial intervention(s) should be described concisely in a table. Describe the investigational trial intervention to be administered in each arm of the trial and for each period of the trial including route and mode of administration, dose, dosage regimen, duration of intervention, use, packaging and labelling. Refer to approved regional labelling, as appropriate. For drug/device combination products, include details on the configuration and use of the device and device manufacturer. A device user manual may be referenced in this section."
}, {
"id": "Composition.section:intervention.section:description.entry",
"path": "Composition.section.section.entry",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition" ]
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}, {
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"path": "Composition.section.section",
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"sliceName": "rationale",
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"min": 1,
"path": "Composition.section.section.text",
"comment": "Provide a rationale for the selection of the dose(s) or dose range, the route of administration, and dosing regimen of the investigational trial intervention. This rationale should include relevant results from previous preclinical studies and clinical trials that support selection of the dose and regimen. Discuss impact of differences in study population characteristics (for example, age, sex and/or race) which could lead to differences in pharmacokinetics and pharmacodynamics in this study as compared to previous studies. If applicable, justify any differences in dose regimen or therapeutic use relative to approved labelling. Describe prior trials and other information that support the dose and/or dose regimen of the investigational intervention. Include a rationale for prospective dose adjustments incorporated in the trial, if any."
}, {
"id": "Composition.section:intervention.section:rationale.entry",
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"type": [ {
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}, {
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}, {
"id": "Composition.section:intervention.section:dosingAdministration.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the detailed procedures for administration of each participant's dose of investigational trial intervention. This may include the timing of dosing (for example, time of day, interval), the duration (for example, the length of time participants will be administered the investigational trial intervention), the planned route of administration (for example, oral, nasal, intramuscular), and the timing of dosing relative to meals. Include any specific instructions to trial participants about when or how to prepare and take the dose(s) and how delayed or missed doses should be handled. Dose escalation or cohort expansion as part of the overall design should be covered in Section 4.1 (Description of Trial Design)."
}, {
"id": "Composition.section:intervention.section:dosingAdministration.entry",
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"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition" ]
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}, {
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"slicing": {
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}, {
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"id": "Composition.section:intervention.section:dosingAdministration.section:doseModification.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "For each participant, describe any dose modifications allowed, including conditions for such dose modifications, particularly regarding failure to respond or safety concerns. State any minimum period required before a participant’s dose might be raised to the next higher dose or dose range. Include whether it is permissible to start and stop treatment and how dose reductions (if permitted) are to be managed. Information on stopping investigational trial intervention for an individua participant due to safety/other reasons should be detailed in Section 7, Participant Discontinuation of Trial Intervention and Withdrawal from Trial."
}, {
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"sliceName": "treatmentOfOverdose",
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"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe what is meant by investigational trial intervention overdose. Provide any available information on managing the overdose and ensure it is consistent with the Investigator’s Brochure or product labelling, cross-references these documents as applicable."
}, {
"id": "Composition.section:intervention.section:treatmentOfOverdose.entry",
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe any preparation of the investigational trial intervention, and when necessary, by whom. When applicable, describe the maximum hold time once thawed/mixed before administration. Include thawing, diluting, mixing, and reconstitution/preparation instructions in this section. For drug/device combination products, include any relevant assembly or use instructions and reference the package insert that is provided separately. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in a separate document(s) provided to the site (for example, a pharmacy manual). If the latter, reference the separate documents."
}, {
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe storage and handling requirements (for example, protection from light, temperature, humidity) for the investigational trial intervention(s). For trials in which multi-dose vials are utilised, provide additional information regarding stability and expiration time after initial use (for example, the seal is broken). State how the investigational trial intervention(s) will be provided to the Investigator. If applicable, describe the kits, packaging, or other material of the investigational trial intervention for blinding purposes. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in a separate document(s) provided to the site (for example, a pharmacy manual). If the latter, reference the separate documents."
}, {
"id": "Composition.section:intervention.section:preparation.section:accountability",
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"sliceName": "accountability",
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}, {
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"patternString": "Accountability of Investigational Trial Intervention"
}, {
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}, {
"id": "Composition.section:intervention.section:preparation.section:accountability.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the accountability method, including how the investigational trial intervention will be distributed and related details, including: •\thow and by whom the investigational trial intervention will be distributed •\tparticipation of a drug storage repository or pharmacy, if applicable, •\tplans for disposal or return of unused product, •\tif applicable, plans for reconciliation of investigational trial intervention."
}, {
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"patternString": "section6.6-assignment-randomisation-blinding"
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}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:assignment",
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the method of assigning participants to investigational trial intervention without being so specific that blinding or randomisation might be compromised. If assignment to investigational trial intervention is by randomisation, describe when randomisation occurs relative to screening. State that at enrollment, participant identification codes should be assigned. If adaptive randomisation or other methods of covariate balancing/minimisation are employed, include a cross-reference to the methods of analysis in Section 10, Statistical Considerations. As applicable, details regarding the implementation of procedures to minimise bias should be described."
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation",
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"sliceName": "randomisation",
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}, {
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"patternString": "section6.6.2-randomisation"
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the randomisation procedures (for example, central randomisation procedures), the method used to generate the randomisation schedule (for example, computer generated), the source of the randomisation schedule (for example, sponsor, investigator, or other), and whether or not IxRS will be used. To maintain the integrity of the blinding, do not include the block size. Describe the use and validation of any computer systems and programmes used for randomisation."
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding",
"max": "1",
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"sliceName": "blinding",
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}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.title",
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"patternString": "Blinding"
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.code.text",
"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "section6.6.3-blinding"
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:blinding.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe efforts to ensure that the investigational trial intervention(s) are as indistinguishable as possible. Plans for the maintenance of randomisation codes and appropriate blinding for the trial should be described. Procedures for planned and unplanned (for example, safety events) breaking of randomisation codes should be provided. If the trial allows for some investigators or other designated staff to remain unblinded (for example, to allow them to adjust investigational trial intervention), the means of maintaining the blinding for other investigators or staff should be explained. Measures to prevent unblinding by laboratory measurements or while performing study assessments, if used, should be described."
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding",
"max": "1",
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"sliceName": "unblinding",
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}, {
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"patternString": "Emergency Unblinding at the Site"
}, {
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"patternString": "section6.6.4-unblinding"
}, {
"id": "Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the criteria for breaking the trial blind or participant code. Describe the circumstances in which the blinding would be broken for an individual or for all participants and who has responsibility. Include the procedure for emergency unblinding such as via IxRS or code envelopes as well as documentation of unblinding. Indicate to whom the intentional and unintentional unblinding should be reported."
}, {
"id": "Composition.section:intervention.section:compliance",
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"path": "Composition.section.section",
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"code": "BackboneElement"
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"sliceName": "compliance",
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}, {
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}, {
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"patternString": "section6.7-intervention-compliance"
}, {
"id": "Composition.section:intervention.section:compliance.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe measures employed to ensure and document dosing information and investigational trial intervention compliance (for example, accountability records, diary cards, or concentration measurements). Include a description of what documents are mandatory to complete (for example, participant drug log) and what source data/records will be used to document investigational trial intervention compliance."
}, {
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"min": 0,
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} ],
"sliceName": "noninvestigationalTherapy",
"mustSupport": true
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.title",
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"patternString": "Non-Investigational Trial Intervention(s)"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section6.8-noninvestigational-interventions"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section",
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
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}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background",
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"sliceName": "background",
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}, {
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"patternString": "Background Intervention"
}, {
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"patternString": "section6.8.1-background-intervention"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:background.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Non-investigational interventions are products used in the context of the trial but are not part of trial objectives and are not investigational trial intervention. Describe background interventions, including administration and any conditions for use."
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue",
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"min": 0,
"path": "Composition.section.section.section",
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}, {
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"patternString": "Rescue Therapy"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.code.text",
"min": 1,
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"patternString": "section6.8.2-rescue-therapy"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "List all rescue medications, treatments, and/or procedures, including any relevant instructions about their administration and any conditions for their use. If administration of rescue therapy leads to the temporary discontinuation of trial intervention or a participant’s withdrawal from the trial, refer to Section 7, Participant Discontinuation of Trial Intervention and Withdrawal from Trial."
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other",
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"sliceName": "other",
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"patternString": "Other Therapy"
}, {
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"min": 1,
"path": "Composition.section.section.section.code.text",
"patternString": "section6.8.3-other-therapy"
}, {
"id": "Composition.section:intervention.section:noninvestigationalTherapy.section:other.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe the use of other non-investigational or auxiliary therapy, for example, challenge agents or diagnostics."
}, {
"id": "Composition.section:intervention.section:concomitantTherapy",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "concomitantTherapy",
"mustSupport": true
}, {
"id": "Composition.section:intervention.section:concomitantTherapy.title",
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"patternString": "Concomitant Therapy"
}, {
"id": "Composition.section:intervention.section:concomitantTherapy.code.text",
"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section6.9-concomitant-therapy"
}, {
"id": "Composition.section:intervention.section:concomitantTherapy.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures which are allowed or prohibited during the trial, and include details about when the information will be collected (for example, screening, all visits). This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed."
}, {
"id": "Composition.section:intervention.section:concomitantTherapy.section",
"path": "Composition.section.section.section",
"slicing": {
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"sliceName": "prohibited",
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}, {
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"patternString": "Prohibited Concomitant Therapy"
}, {
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"id": "Composition.section:intervention.section:concomitantTherapy.section:prohibited.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe any prohibited concomitant therapy."
}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If applicable, describe any permitted concomitant therapy."
}, {
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"min": 1,
"path": "Composition.section",
"sliceName": "dropout",
"mustSupport": true
}, {
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"path": "Composition.section.title",
"patternString": "Participant Discontinuation of Trial Intervention and Withdrawal from Trial"
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"patternString": "section7-participant-discontinuation"
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"min": 4,
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}, {
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"sliceName": "discontinuation",
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Discontinuation of trial intervention for a participant occurs when trial intervention is stopped earlier than the protocol planned duration. Describe the criteria for discontinuation of a participant from any trial intervention, carefully evaluating which are appropriate for the trial population and therapy being studied. Specify whether participants who discontinue trial intervention can or cannot continue the trial (continue trial visits). Refer to the Section 1.3 Schedule of Activities for assessments to be performed at the time of and following discontinuation of trial intervention. Explain the process for collecting and recording the detailed reasons for discontinuing trial intervention(s)."
}, {
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"min": 1,
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"sliceName": "temporary",
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}, {
"id": "Composition.section:dropout.section:discontinuation.section:temporary.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe •\tthe criteria for temporary discontinuation or interruption of trial intervention for an individual participant •\twhat to do and which restrictions still apply if the participant needs to temporarily discontinue or interrupt trial intervention •\twhether they will continue in the trial, and • whether all, or specify which, assessments will be performed for the stated duration of the trial. Details of any rechallenge or restart after a safety-related event should be included in Section 7.1.3, Rechallenge."
}, {
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge",
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"sliceName": "rechallenge",
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}, {
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"patternString": "Rechallenge"
}, {
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"patternString": "section7.1.3-rechallenge"
}, {
"id": "Composition.section:dropout.section:discontinuation.section:rechallenge.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe the criteria for rechallenge/restarting trial intervention, how to perform rechallenge, number of rechallenges allowed during the trial, and whether all, or specify which, assessments will be performed for the stated duration of the trial. If rechallenge is not allowed, state this."
}, {
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"sliceName": "withdrawal",
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}, {
"id": "Composition.section:dropout.section:withdrawal.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the criteria for participant withdrawal from the trial. Describe the reason for withdrawal and the type and data to be collected for the final assessments with reference to the schedule of activities for the participant end of study visit unless provided in another section."
}, {
"id": "Composition.section:dropout.section:lostToFollowUp",
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"patternString": "section7.3-lost-to-follow-up"
}, {
"id": "Composition.section:dropout.section:lostToFollowUp.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the measures to be taken to reduce the frequency of participants lost to follow up. Describe how the trial will define and address participants who are lost to follow-up to help limit the amount and impact of missing data. Describe the nature and duration of follow-up, as appropriate."
}, {
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"id": "Composition.section:dropout.section:trialStoppingRules.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "If applicable, describe any trial-specific stopping rules that would apply to individual participants such as treatment or study non-compliance or due to safety reasons. Address the procedure ensuring alignment with the intercurrent events and their handling strategies introduced in Section 3."
}, {
"id": "Composition.section:assessments",
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"path": "Composition.section",
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"comment": "Include any specific instructions for the collection and interpretation of clinical laboratory assessments. •\tType of laboratory (central/local/hybrid) •\tacceptability of additional tests deemed necessary by the investigator or local regulations •\tinstructions for situations in which central laboratory results are not available in time for trial intervention and/or response evaluation, or in the event of a severe disruption (for example, a pandemic or natural disaster) •\ttreatment algorithms for results out of normal range •\tCross-refer to Section 13.2 for lab assessment panels"
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"comment": "Include any specific instructions for the collection and assay of samples for genetic analysis. If genetic testing is not included in the study, state Not Applicable. •\tDescribe the biological samples that will be collected (for example, tissue, serum, plasma, etc.), handling of samples, and the assay method. o\tSpecific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. •\tDescribe the retention time for the samples (ensuring alignment with the ICF). •\tIndicate the types of analyses that may be studied for each sample."
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"min": 1,
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"comment": "Include any specific instructions for the collection of samples and interpretation of immunogenicity. If immunogenicity assessments are included within Efficacy Assessments or Safety Assessments, cross-reference to that section. If immunogenicity testing is not included in the study, state Not Applicable."
}, {
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"min": 1,
"path": "Composition.section.section.text",
"comment": "This section does not apply to COAs. Include this section only for any value evidence and outcomes assessments not included in either the efficacy or safety sections. If medical resource utilization and health economics assessment is not included in the study, state Not Applicable. Describe the health outcome measures, collection method (for example, diary, physician interview), and participant burden."
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"comment": "Specify the SAE definitions, including: •\tAny relevant regional SAE requirements. •\tAny events that meet and do not meet the SAE definition. •\tAny trial-specific SAE clarifications."
}, {
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"comment": "Specify how AEs and SAEs will be identified (for example, spontaneous reporting, solicited questions)."
}, {
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}, {
"id": "Composition.section:adverseEvents.section:recording.section:intensity.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the intensity rating categories/scale."
}, {
"id": "Composition.section:adverseEvents.section:recording.section:causality",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
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} ],
"sliceName": "causality",
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"patternString": "Causality"
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}, {
"id": "Composition.section:adverseEvents.section:recording.section:causality.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify: •\tThe causality categories/scale. •\tProcedures for assessing causality."
}, {
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
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} ],
"sliceName": "recordingEvents",
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}, {
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.title",
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"patternString": "Recording of AEs, SAEs, Pregnancy and Product Complaints"
}, {
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"path": "Composition.section.section.section.code.text",
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}, {
"id": "Composition.section:adverseEvents.section:recording.section:recordingEvents.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the Investigator's actions for recording AEs and SAEs, including severity, causality, and the final outcome."
}, {
"id": "Composition.section:adverseEvents.section:recording.section:followup",
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"min": 1,
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}, {
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}, {
"id": "Composition.section:adverseEvents.section:recording.section:followup.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the procedures for follow-up of AEs, SAEs, pregnancy and product complaints. Include the assessment tools that will be used to monitor the events and the duration of follow-up after appearance of the events. Specify any procedures to be used for trials in which death is not an endpoint."
}, {
"id": "Composition.section:adverseEvents.section:reporting",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "reporting",
"mustSupport": true
}, {
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"patternString": "Reporting of AEs, SAEs, Pregnancy, and Product Complaints"
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"patternString": "section9.4-reporting-events"
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}
}, {
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}, {
"id": "Composition.section:adverseEvents.section:reporting.section:reportingSAEs.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the SAE reporting method (for example, an electronic data collection tool or a paper CRF) and reporting timeline to the Sponsor."
}, {
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements",
"max": "1",
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"path": "Composition.section.section.section",
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"sliceName": "regulatoryRequirements",
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}, {
"id": "Composition.section:adverseEvents.section:reporting.section:regulatoryRequirements.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify: •\tThe investigators’ responsibilities for reporting SAEs and Medical Device Product Complaints to the Sponsor (and to Ethics Committees, where required), specifying timing of reporting to allow the Sponsor to meet their responsibilities •\tThe Sponsor’s legal/regulatory responsibilities to report SAEs to regulatory authorities, ethics committees, and investigators •\tSerious and unexpected adverse reaction reporting"
}, {
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest",
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"min": 1,
"path": "Composition.section.section.section",
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} ],
"sliceName": "specialInterest",
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}, {
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}, {
"id": "Composition.section:adverseEvents.section:reporting.section:specialInterest.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify any Adverse Events of Special Interest (AESI): •\tOther events that merit reporting to the Sponsor, trial leadership, IRB, and regulatory agencies (for example, secondary malignancies in oncology trials). •\tOther reportable events not already included in the previous sections, such as cardiovascular events, medical device incidents (including malfunctions), laboratory test abnormalities, and trial intervention overdose. Include the following for each AESI: •\tThe definition of the event. Specify the MedDRA preferred terms to use to report the AESI. •\tIf it is a measurable quantity, specify how will the measurement be done. •\tIf it is a clinical event, specify how will it be confirmed."
}, {
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents",
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"min": 1,
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"sliceName": "diseaseRelatedEvents",
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"patternString": "Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"
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"patternString": "section9.4.4-disease-related-events"
}, {
"id": "Composition.section:adverseEvents.section:reporting.section:diseaseRelatedEvents.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify any Disease-Related Events (DREs), disease-related outcomes (DROs), or both that will not be reported as AEs or SAEs (for example, seizures in anticonvulsant trials) or state not applicable."
}, {
"id": "Composition.section:adverseEvents.section:pregnancy",
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}, {
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"patternString": "Participants Who Become Pregnant During the Trial"
}, {
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"patternString": "section9.5.1-pregnant"
}, {
"id": "Composition.section:adverseEvents.section:pregnancy.section:pregnant.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "See Template for instructions."
}, {
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"patternString": "section9.5.2-pregnant-partner"
}, {
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"min": 1,
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"comment": "See Template for instructions."
}, {
"id": "Composition.section:statistics",
"max": "1",
"min": 1,
"path": "Composition.section",
"sliceName": "statistics",
"mustSupport": true
}, {
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"patternString": "section10-statistics"
}, {
"id": "Composition.section:statistics.text",
"min": 1,
"path": "Composition.section.text",
"comment": "Ensure that the data analysis complies with ICH E9 Guideline and ICH E9(R1) Guideline. In general, all relevant data collected in the trial should be considered in this statistical considerations section. Provide a statement with regard to when the primary analyses will be conducted. For example: The analysis will be conducted on all participant data at the time the trial ends."
}, {
"id": "Composition.section:statistics.section",
"min": 4,
"path": "Composition.section.section",
"slicing": {
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}, {
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} ],
"sliceName": "analysisSets",
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}, {
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}, {
"id": "Composition.section:statistics.section:analysisSets.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Analysis sets to support each analysis will be specified here and described in the Statistical Analysis Plan."
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective",
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"min": 1,
"path": "Composition.section.section",
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"sliceName": "analysisPrimaryObjective",
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"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
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}, {
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"min": 1,
"path": "Composition.section.section.text",
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}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section",
"min": 3,
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"slicing": {
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}, {
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"path": "Composition.section.section.section",
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"sliceName": "statisticalModel",
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}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.text",
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"comment": "Ensure that the statistical hypothesis/model (and corresponding assumptions)/analysis is aligned with the primary estimand(s). For all applicable objectives (for example, primary, secondary), under the appropriate header, state the null and alternative hypotheses, including the pre-planned type 1 error, or alternative criteria to define trial success and relevant operating characteristics if appropriate. Describe the statistical model used and the factors that will be included (covariates and interactions) and any rules for handling these factors (for example, pooling of centres). If applicable, state and describe any adjustments to account for multiplicity. If modelling and simulation methods are to be used, please describe the model (inputs and outputs), the underlying assumptions, and the method of model fitting."
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:statisticalModel.entry",
"path": "Composition.section.section.section.entry",
"type": [ {
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"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan" ]
} ]
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling",
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"path": "Composition.section.section.section",
"type": [ {
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} ],
"sliceName": "intercurrentEventHandling",
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}, {
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"patternString": "Handling of Intercurrent Events of Primary Estimand"
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"patternString": "section10.2.2-intercurrent-events-handling"
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"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:intercurrentEventHandling.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "For each intercurrent event of the primary estimand(s) (Section 3.1, Estimand[s] for the Primary Objective[s]), explain how data will be handled for the statistical analysis in line with the primary estimand. The handling of intercurrent events in statistical analysis should be aligned with the specific estimand strategies being used. This section should describe with more detail the rationale and handling of the data rather than repeating the guidance from the preceding sections."
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData",
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"min": 1,
"path": "Composition.section.section.section",
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"sliceName": "missingData",
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}, {
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"patternString": "section10.2.3-missing-data-handling"
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:missingData.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "This section should describe how missing data will be dealt with. Refer to the E9(R1) addendum when estimand framework is used. The protocol should describe how missing data will be handled (for example, type of imputation technique, if any, and provide justification). In cases where the Primary Objective is related to safety, this section should also be completed. It may also be helpful to include additional statements regarding handling of missing data in general for other important efficacy or safety endpoints or this information can be included in the analysis of secondary endpoint section below."
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis",
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"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Sensitivity analyses are a series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying modelling assumptions and limitations in the data."
}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:sensitvityAnalysis.entry",
"path": "Composition.section.section.section.entry",
"type": [ {
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}, {
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}, {
"id": "Composition.section:statistics.section:analysisPrimaryObjective.section:supplementaryAnalysis.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Describe any supplementary analysis if applicable."
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"min": 0,
"path": "Composition.section.section",
"type": [ {
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"targetProfile": [ "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition" ]
} ]
}, {
"id": "Composition.section:statistics.section:secondaryAnalysis.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "This section introduces the Statistical Analysis Plan, with the detail to be provided in the subsequent subsections. This includes describing the methods of estimation (analytic approach) in alignment with how the estimands are defined. Sensitivity analyses should be aligned with how the estimands and estimators are defined."
}, {
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"sliceName": "statisticalModel",
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"id": "Composition.section:statistics.section:secondaryAnalysis.section:statisticalModel.code.text",
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"id": "Composition.section:statistics.section:safetyAnalyses.text",
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"path": "Composition.section.section.text",
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}, {
"id": "Composition.section:statistics.section:otherAnalyses",
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}, {
"id": "Composition.section:statistics.section:otherAnalyses.text",
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"path": "Composition.section.section.text",
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}, {
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}, {
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"min": 1,
"path": "Composition.section.section.text",
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}, {
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}, {
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"comment": "Describe the sponsor duties to be delegated to a third party that may impact the investigators sites, if applicable."
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"comment": "Specify the key elements of the informed consent process, including any special needs and how these are addressed (for example, assent, capacity, legally acceptable representative, adolescents who may reach age of majority during the trial, pregnant participants and pregnant partners of participants)."
}, {
"id": "Composition.section:oversight.section:informedConsent.section",
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
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}
}, {
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"min": 0,
"path": "Composition.section.section.section",
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"code": "BackboneElement"
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"sliceName": "assentProcess",
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}, {
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.title",
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}, {
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"patternString": "section11.4.0-assent-process"
}, {
"id": "Composition.section:oversight.section:informedConsent.section:assentProcess.text",
"min": 1,
"path": "Composition.section.section.section.text"
}, {
"id": "Composition.section:oversight.section:informedConsent.section:emergency",
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"min": 0,
"path": "Composition.section.section.section",
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"sliceName": "emergency",
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}, {
"id": "Composition.section:oversight.section:informedConsent.section:emergency.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If enrollment in the trial may occur during an emergency in which the participant or their legally acceptable representative is not able or available to give consent, describe the consent process."
}, {
"id": "Composition.section:oversight.section:informedConsent.section:rescreening",
"max": "1",
"min": 0,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "rescreening",
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}, {
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}, {
"id": "Composition.section:oversight.section:informedConsent.section:rescreening.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If participants can be rescreened, add the text to state whether the participant needs to complete a new consent. Screen failure and rescreening should be clearly defined in the protocol, with cross-reference to those definitions."
}, {
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples",
"max": "1",
"min": 0,
"path": "Composition.section.section.section",
"type": [ {
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} ],
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"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.title",
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"patternString": "Informed Consent for Remaining Samples in Exploratory Research"
}, {
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"patternString": "section11.4.2-remaining-samples"
}, {
"id": "Composition.section:oversight.section:informedConsent.section:remainingSamples.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "If any exploratory research is planned and additional written consent regarding the use of remaining samples for exploratory research will be obtained, describe the consent process."
}, {
"id": "Composition.section:oversight.section:insurance",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "insurance",
"mustSupport": true
}, {
"id": "Composition.section:oversight.section:insurance.title",
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}, {
"id": "Composition.section:oversight.section:insurance.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the arrangements for participants insurance and indemnity if not addressed in a separate agreement."
}, {
"id": "Composition.section:oversight.section:earlySiteClosure",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
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}, {
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"min": 3,
"path": "Composition.section.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
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}
}, {
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "List the sponsor's rights to close a site. Likewise, list the investigator's rights to initiate early site closure."
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria",
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"min": 1,
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"sliceName": "criteria",
"mustSupport": true
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.title",
"path": "Composition.section.section.section.title",
"patternString": "Crteria for Early Closure"
}, {
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"min": 1,
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"patternString": "section11.6-early-site-closure#criteria"
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:criteria.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "List the criteria for early closure of a site by the sponsor or investigator."
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "responsibilities",
"mustSupport": true
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.title",
"path": "Composition.section.section.section.title",
"patternString": "Responsibilities Following Early Site Closure"
}, {
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"min": 1,
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"patternString": "section11.6-early-site-closure#responsibilities"
}, {
"id": "Composition.section:oversight.section:earlySiteClosure.section:responsibilities.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "List the responsibilities of the sponsor and investigator following early site closure, such as informing the ethics committee(s), and prompt notification of the participant and transition to appropriate therapy and/or follow-up."
}, {
"id": "Composition.section:riskManagementAndData",
"max": "1",
"min": 1,
"path": "Composition.section",
"sliceName": "riskManagementAndData",
"mustSupport": true
}, {
"id": "Composition.section:riskManagementAndData.title",
"path": "Composition.section.title",
"patternString": "General Considerations: Risk Management and Data Governance"
}, {
"id": "Composition.section:riskManagementAndData.code.text",
"min": 1,
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}, {
"id": "Composition.section:riskManagementAndData.section",
"min": 3,
"path": "Composition.section.section",
"slicing": {
"rules": "open",
"discriminator": [ {
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}
}, {
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"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "riskManagement",
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}, {
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"patternString": "section12.1-risk-management"
}, {
"id": "Composition.section:riskManagementAndData.section:riskManagement.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe how the critical to quality factors will be mitigated. It is important to determine the risks that threaten their integrity and decide whether they can be accepted or should be mitigated, based on their probability, detectability and impact. Where it is decided that risks should be mitigated, the necessary control processes should be put in place and communicated, and the necessary actions taken to mitigate the risks."
}, {
"id": "Composition.section:riskManagementAndData.section:dataGovernance",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
} ],
"sliceName": "dataGovernance",
"mustSupport": true
}, {
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}, {
"id": "Composition.section:riskManagementAndData.section:dataGovernance.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Describe the key processes for critical trial integrity, traceability and security enabling accurate collection, reporting, monitoring, transfer, retention, access and publication if not addressed in separate agreement(s). Describe the measures to protect the privacy and confidentiality of personal information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach."
}, {
"id": "Composition.section:riskManagementAndData.section:sourceData",
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"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
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"sliceName": "sourceData",
"mustSupport": true
}, {
"id": "Composition.section:riskManagementAndData.section:sourceData.title",
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"patternString": "Source Data"
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"min": 1,
"path": "Composition.section.section.code.text",
"patternString": "section12.3-source-data"
}, {
"id": "Composition.section:riskManagementAndData.section:sourceData.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Establish the importance of source data and expectation for traceability of transcribed information back to source. Delineate expectations for investigators (for example, maintain source data at the site, ensure availability of current records) and trial monitors (for example, verify CRF data relative to source, safety of participants is being protected, conduct is in accordance with GCP). Define what constitutes source data and its origin or provide a reference to the location of these definitions, if contained in a separate document, such as a monitoring guideline or source data acknowledgement). Describe the provision for direct access to source data and documents enabling clinical trial-related monitoring, audits and regulatory inspections, if not included in separate agreement(s)."
}, {
"id": "Composition.section:definitions",
"max": "1",
"min": 1,
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"mustSupport": true
}, {
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"patternString": "Appendix: Definitions and Supporting Operational Details"
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}
}, {
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}, {
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"min": 1,
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"sliceName": "contraceptionDefinitions",
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}, {
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"path": "Composition.section.section.section.title",
"patternString": "Definitions Related to Childbearing Potential"
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"patternString": "section13.1.1-contraception-definitions"
}, {
"id": "Composition.section:definitions.section:contraception.section:contraceptionDefinitions.text",
"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the definitions of Participant of childbearing potential and Participant of non-childbearing potential, or state Not Applicable."
}, {
"id": "Composition.section:definitions.section:contraception.section:contraceptionDetails",
"max": "1",
"min": 1,
"path": "Composition.section.section.section",
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}, {
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"min": 1,
"path": "Composition.section.section.section.text",
"comment": "Specify the contraceptive methods required and duration of use, or state Not Applicable."
}, {
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"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
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}, {
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.title",
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"patternString": "Clinical Laboratory Tests"
}, {
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}, {
"id": "Composition.section:definitions.section:clinicalLaboratoryTests.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Specify which laboratory parameters should be included in each clinical laboratory assessment panel (for example, for haematology, chemistry, urinalysis). A tabular presentation for such information is common. If applicable, include equations and references for locally calculated laboratory results. If not applicable, retain header and enter Not Applicable."
}, {
"id": "Composition.section:definitions.section:regional",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
"code": "BackboneElement"
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}, {
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"path": "Composition.section.section.title",
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"path": "Composition.section.section.code.text",
"patternString": "section13.3-country-specific-differences"
}, {
"id": "Composition.section:definitions.section:regional.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Although global clinical trial practices are increasingly harmonised, some country/ region-specific differences in requirements do exist (for example, document retention periods, contraception requirements). Where differences in requirements cannot be reconciled, sponsors should explain how they will document and communicate country/region-specific differences (for example, by country/region-specific amendments or addenda). An alternative to country/region-specific amendments is to list the specific differences by country or countries in this section, including a reference to the relevant section of the protocol where the differing requirement applies. If not applicable, retain header and enter Not Applicable."
}, {
"id": "Composition.section:definitions.section:priorAmendments",
"max": "1",
"min": 1,
"path": "Composition.section.section",
"type": [ {
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"sliceName": "priorAmendments",
"mustSupport": true
}, {
"id": "Composition.section:definitions.section:priorAmendments.title",
"path": "Composition.section.section.title",
"patternString": "Prior Protocol Amendment(s)"
}, {
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"min": 1,
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}, {
"id": "Composition.section:definitions.section:priorAmendments.text",
"min": 1,
"path": "Composition.section.section.text",
"comment": "Either enter value of {Not applicable. The protocol has not been amended.} or {Not applicable. This is the first protocol amendment.} or SEE TEMPLATE INSTRUCTIONS."
}, {
"id": "Composition.section:glossary",
"max": "1",
"min": 1,
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"id": "Composition.section:glossary.text",
"min": 1,
"path": "Composition.section.text",
"comment": "Define abbreviations and other terms used in the protocol. A tabular presentation is common and may serve as the definition at first use."
}, {
"id": "Composition.section:glossary.entry",
"path": "Composition.section.entry",
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"code": "Reference",
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}, {
"id": "Composition.section:references",
"max": "1",
"min": 1,
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"min": 1,
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"patternString": "section15-references"
}, {
"id": "Composition.section:references.text",
"min": 1,
"path": "Composition.section.text",
"comment": "References should be listed in a common format that includes all relevant information to identify the source and date published. If not published, this should be clearly indicated."
}, {
"id": "Composition.section:references.entry",
"path": "Composition.section.entry",
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"code": "Reference",
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},
"contact": [ {
"name": "HL7 International / Clinical Decision Support",
"telecom": [ {
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