{
"description": "Abbildung eines Additives, das zu einer Probe hinzugefĆ¼gt werden kann",
"_filename": "StructureDefinition-Substance.json",
"package_name": "de.medizininformatikinitiative.kerndatensatz.biobank",
"date": null,
"derivation": "constraint",
"publisher": null,
"fhirVersion": "4.0.1",
"name": "ProfileSubstanceAdditiv",
"abstract": false,
"type": "Substance",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "Profile - Substance - Additiv",
"package_version": "2025.0.3",
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"xpath": "not(parent::f:contained and f:contained)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.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",
"xpath": "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"xpath": "exists(f:text/h:div)",
"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()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"xpath": "not(exists(f:contained/*/f:meta/f:security))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
} ],
"path": "Substance",
"min": 0,
"definition": "A homogeneous material with a definite composition.",
"short": "A homogeneous material with a definite composition",
"mapping": [ {
"map": "Entity. Role, or Act",
"identity": "rim"
}, {
"map": "Material",
"identity": "rim"
}, {
"map": "fhir:Substance rdfs:subClassOf rim:Entity, [ a owl:Restriction; owl:onProperty rim:Act.classCode; owl:allValuesFrom cs:EntityClass\\#MAT ].",
"identity": "orim"
} ],
"max": "*",
"id": "Substance",
"base": {
"max": "*",
"min": 0,
"path": "Substance"
}
}, {
"path": "Substance.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"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": "string"
} ]
} ],
"max": "1",
"id": "Substance.id",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.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.",
"short": "Metadata about the resource",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Meta"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "1",
"id": "Substance.meta",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.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",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "Substance.implicitRules",
"condition": [ "ele-1" ],
"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 it's 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 it's meaning or interpretation",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"short": "Language of the resource content",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/languages",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical": "http://hl7.org/fhir/ValueSet/all-languages"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "A human language."
},
"max": "1",
"id": "Substance.language",
"condition": [ "ele-1" ],
"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"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.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.",
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "N/A",
"identity": "rim"
}, {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "Substance.text",
"condition": [ "ele-1" ],
"comment": "Contained resources do not have 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"
}
}, {
"path": "Substance.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"short": "Contained, inline Resources",
"mapping": [ {
"map": "Entity. Role, or Act",
"identity": "rim"
}, {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "Substance.contained",
"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"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"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"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Substance.extension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.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 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 manageable, 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"
}, {
"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"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Substance.modifierExtension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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"
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.identifier",
"min": 0,
"definition": "Unique identifier for the substance.",
"short": "Unique identifier",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
"identity": "v2"
}, {
"map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]",
"identity": "rim"
}, {
"map": "Identifier",
"identity": "servd"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
}, {
"map": ".id",
"identity": "rim"
} ],
"type": [ {
"code": "Identifier"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "*",
"id": "Substance.identifier",
"condition": [ "ele-1" ],
"comment": "This identifier is associated with the kind of substance in contrast to the Substance.instance.identifier which is associated with the package/container.",
"base": {
"max": "*",
"min": 0,
"path": "Substance.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.status",
"min": 0,
"definition": "A code to indicate if the substance is actively used.",
"isModifier": true,
"short": "active | inactive | entered-in-error",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "FiveWs.status",
"identity": "w5"
}, {
"map": ".statusCode",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-status|4.0.1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "FHIRSubstanceStatus"
} ],
"description": "A code to indicate if the substance is actively used."
},
"max": "1",
"id": "Substance.status",
"condition": [ "ele-1" ],
"comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
"base": {
"max": "1",
"min": 0,
"path": "Substance.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",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.category",
"min": 0,
"definition": "A code that classifies the general type of substance. This is used for searching, sorting and display purposes.",
"short": "What class/type of substance this is",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "CE/CNE/CWE",
"identity": "v2"
}, {
"map": "CD",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
"identity": "orim"
}, {
"map": "FiveWs.class",
"identity": "w5"
}, {
"map": ".code",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-category",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceCategory"
} ],
"description": "Category or classification of substance."
},
"max": "*",
"id": "Substance.category",
"condition": [ "ele-1" ],
"comment": "The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Substance.code.",
"base": {
"max": "*",
"min": 0,
"path": "Substance.category"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.code",
"min": 1,
"definition": "A code (or set of codes) that identify this substance.",
"short": "What substance this is",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "CE/CNE/CWE",
"identity": "v2"
}, {
"map": "CD",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
"identity": "orim"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": ".code",
"identity": "rim"
}, {
"map": "fhir:Substance.code rdfs:subPropertyOf rim:Entity.code",
"identity": "orim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"binding": {
"strength": "extensible",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-biobank/ValueSet/additive",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceCode"
} ],
"description": "Substance codes."
},
"max": "1",
"id": "Substance.code",
"condition": [ "ele-1" ],
"comment": "This could be a reference to an externally defined code. It could also be a locally assigned code (e.g. a formulary), optionally with translations to the standard drug codes.",
"base": {
"max": "1",
"min": 1,
"path": "Substance.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.description",
"min": 0,
"definition": "A description of the substance - its appearance, handling requirements, and other usage notes.",
"short": "Textual description of the substance, comments",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": ".player.desc",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "Substance.description",
"condition": [ "ele-1" ],
"comment": "Note that FHIR strings SHALL NOT exceed 1MB in size",
"base": {
"max": "1",
"min": 0,
"path": "Substance.description"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.instance",
"min": 0,
"definition": "Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance.",
"short": "If this describes a specific package/container of the substance",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": ".player.determinerCode",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"meaningWhenMissing": "If this element is not present, then the substance resource describes a kind of substance",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "*",
"id": "Substance.instance",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "Substance.instance"
},
"isSummary": true
}, {
"path": "Substance.instance.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"short": "Unique id for inter-element referencing",
"mapping": [ {
"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": "Substance.instance.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.instance.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"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"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Substance.instance.extension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.instance.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though 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"
}, {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Substance.instance.modifierExtension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.instance.identifier",
"min": 0,
"definition": "Identifier associated with the package/container (usually a label affixed directly).",
"short": "Identifier of the package/container",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
"identity": "v2"
}, {
"map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]",
"identity": "rim"
}, {
"map": "Identifier",
"identity": "servd"
}, {
"map": ".id",
"identity": "rim"
} ],
"type": [ {
"code": "Identifier"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "1",
"id": "Substance.instance.identifier",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Substance.instance.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.instance.expiry",
"min": 0,
"definition": "When the substance is no longer valid to use. For some substances, a single arbitrary date is used for expiry.",
"short": "When no longer valid to use",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": ".expiryTime",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"max": "1",
"id": "Substance.instance.expiry",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Substance.instance.expiry"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "qty-3",
"human": "If a code for the unit is present, the system SHALL also be present",
"xpath": "not(exists(f:code)) or exists(f:system)",
"source": "http://hl7.org/fhir/StructureDefinition/Quantity",
"severity": "error",
"expression": "code.empty() or system.exists()"
}, {
"key": "sqty-1",
"human": "The comparator is not used on a SimpleQuantity",
"xpath": "not(exists(f:comparator))",
"source": "http://hl7.org/fhir/StructureDefinition/SimpleQuantity",
"severity": "error",
"expression": "comparator.empty()"
} ],
"path": "Substance.instance.quantity",
"min": 0,
"definition": "The amount of the substance.",
"isModifier": false,
"short": "Amount of substance in the package",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "SN (see also Range) or CQ",
"identity": "v2"
}, {
"map": "PQ, IVL, MO, CO, depending on the values",
"identity": "rim"
}, {
"map": ".player.quantity",
"identity": "rim"
} ],
"type": [ {
"code": "Quantity",
"profile": [ "http://hl7.org/fhir/StructureDefinition/SimpleQuantity" ]
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "1",
"id": "Substance.instance.quantity",
"condition": [ "ele-1" ],
"comment": "The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.",
"base": {
"max": "1",
"min": 0,
"path": "Substance.instance.quantity"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.ingredient",
"min": 0,
"definition": "A substance can be composed of other substances.",
"short": "Composition information about the substance",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": ".player.scopesRole[classCode=INGR]",
"identity": "rim"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "*",
"id": "Substance.ingredient",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "Substance.ingredient"
},
"isSummary": true
}, {
"path": "Substance.ingredient.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"short": "Unique id for inter-element referencing",
"mapping": [ {
"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": "Substance.ingredient.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.ingredient.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"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"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "Substance.ingredient.extension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Substance.ingredient.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though 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"
}, {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "Substance.ingredient.modifierExtension",
"condition": [ "ele-1" ],
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "rat-1",
"human": "Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present",
"xpath": "(count(f:numerator) = count(f:denominator)) and ((count(f:numerator) > 0) or (count(f:extension) > 0))",
"source": "http://hl7.org/fhir/StructureDefinition/Ratio",
"severity": "error",
"expression": "(numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())"
} ],
"path": "Substance.ingredient.quantity",
"min": 0,
"definition": "The amount of the ingredient in the substance - a concentration ratio.",
"short": "Optional amount (concentration)",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": "N/A",
"identity": "v2"
}, {
"map": "RTO",
"identity": "rim"
}, {
"map": ".quantity",
"identity": "rim"
} ],
"type": [ {
"code": "Ratio"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"max": "1",
"id": "Substance.ingredient.quantity",
"condition": [ "ele-1" ],
"comment": "The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to \"1\", Quantity should be used instead of Ratio.",
"base": {
"max": "1",
"min": 0,
"path": "Substance.ingredient.quantity"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Substance.ingredient.substance[x]",
"min": 1,
"definition": "Another substance that is a component of this substance.",
"short": "A component of the substance",
"mapping": [ {
"map": "n/a",
"identity": "rim"
}, {
"map": ".player",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
}, {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Substance" ]
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "normative"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
"valueCode": "4.0.0"
} ],
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/substance-code",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "SubstanceIngredient"
} ],
"description": "Substance Ingredient codes."
},
"max": "1",
"id": "Substance.ingredient.substance[x]",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 1,
"path": "Substance.ingredient.substance[x]"
},
"isSummary": true
} ]
},
"status": "active",
"id": "0160c0ba-eab4-41f2-b9f1-d7abdc6aaf27",
"kind": "resource",
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-biobank/StructureDefinition/Substance",
"version": "2025.0.2",
"differential": {
"element": [ {
"id": "Substance.category",
"path": "Substance.category",
"mustSupport": true
}, {
"id": "Substance.code",
"path": "Substance.code",
"binding": {
"strength": "extensible",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-biobank/ValueSet/additive"
},
"mustSupport": true
}, {
"id": "Substance.ingredient",
"path": "Substance.ingredient",
"mustSupport": true
} ]
},
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Substance"
}