{ "description": "ClinicalUseDefinition Undesirable Effect (ePI)", "_filename": "StructureDefinition-ClinicalUseDefinition-undesirableEffect-uv-epi.json", "package_name": "hl7.fhir.uv.emedicinal-product-info", "date": "2022-12-04T18:49:33+00:00", "derivation": "constraint", "publisher": null, "fhirVersion": "5.0.0-ballot", "jurisdiction": [ { "coding": [ { "code": "001", "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "display": "World" } ] } ], "name": "ClinicalUseDefinitionUndesirableEffectUvEpi", "mapping": [ { "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products", "name": "IDMP Mapping", "identity": "idmp" }, { "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping", "identity": "w5" }, { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" } ], "abstract": false, "type": "ClinicalUseDefinition", "experimental": null, "resourceType": "StructureDefinition", "title": "ClinicalUseDefinition Undesirable Effect (ePI)", "package_version": "1.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Medication Definition" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "anonymous" } ], "snapshot": { "element": [ { "constraint": [ { "key": "cud-1", "human": "Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance", "xpath": "count(f:ClinicalUseDefinition/f:indication|f:ClinicalUseDefinition/f:contraindication|f:ClinicalUseDefinition/f:interaction|f:ClinicalUseDefinition/f:undesirableEffect|f:ClinicalUseDefinition/f:warning) < 2", "source": "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition", "severity": "error", "expression": "(ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2" }, { "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-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 $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))", "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(as(canonical) = '#').exists() or descendants().where(as(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", "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-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()" }, { "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()" } ], "path": "ClinicalUseDefinition", "min": 0, "definition": "A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.", "isModifier": false, "short": "A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure", "mapping": [ { "map": "Entity. Role, or Act", "identity": "rim" }, { "map": "Contraindication, Therapeutic Indication, Interactions, Undesirable Effects", "identity": "idmp" }, { "map": "clinical.general", "identity": "w5" } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition" }, "isSummary": false }, { "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.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 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": "ClinicalUseDefinition.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": "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": "IETF language tag" }, "max": "1", "id": "ClinicalUseDefinition.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.text", "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": "ClinicalUseDefinition.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": "ClinicalUseDefinition.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" }, "isSummary": false }, { "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": "ClinicalUseDefinition.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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "mustSupport": false, "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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" }, "isSummary": false }, { "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": "ClinicalUseDefinition.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "mustSupport": false, "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.identifier", "min": 0, "definition": "Business identifier for this issue.", "isModifier": false, "short": "Business identifier for this clinical use.", "mapping": [ { "map": "FiveWs.class", "identity": "w5" }, { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "Identifier" } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.identifier", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.type", "min": 1, "definition": "indication | contraindication | interaction | undesirable-effect | warning.", "isModifier": false, "short": "indication | contraindication | interaction | undesirable-effect | warning", "mapping": [ { "map": "(the type of IDMP class, out of Contraindication, Therapeutic Indication, Interactions, Undesirable Effects)", "identity": "idmp" } ], "type": [ { "code": "code" } ], "mustSupport": false, "patternCode": "undesirable-effect", "binding": { "strength": "required", "valueSet": "http://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ClinicalUseDefinitionType" } ], "description": "Overall defining type of this clinical use definition." }, "max": "1", "id": "ClinicalUseDefinition.type", "base": { "max": "1", "min": 1, "path": "ClinicalUseDefinition.type" }, "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": "ClinicalUseDefinition.category", "min": 0, "definition": "A categorisation of the issue, primarily for dividing warnings into subject heading areas such as \"Pregnancy and Lactation\", \"Overdose\", \"Effects on Ability to Drive and Use Machines\".", "isModifier": false, "short": "A categorisation of the issue, primarily for dividing warnings into subject heading areas such as \"Pregnancy\", \"Overdose\"", "mapping": [ { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/clinical-use-definition-category", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ClinicalUseDefinitionCategory" } ], "description": "A categorisation for a clinical use information item." }, "max": "*", "id": "ClinicalUseDefinition.category", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.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": "ClinicalUseDefinition.subject", "min": 1, "definition": "The medication or procedure for which this is an indication.", "isModifier": false, "short": "The medication or procedure for which this is an indication", "mapping": [ { "map": "(the link between the IDMP class and Medicinal Product)", "identity": "idmp" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi" ] } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.subject", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.subject" }, "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": "ClinicalUseDefinition.status", "min": 0, "definition": "Whether this is a current issue or one that has been retired etc.", "isModifier": false, "short": "Defines whether this clinical use is draft, active or retired", "mapping": [ { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/publication-status", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PublicationStatus" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", "valueBoolean": true } ], "description": "The lifecycle status of an artifact." }, "max": "1", "id": "ClinicalUseDefinition.status", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.status" }, "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": "ClinicalUseDefinition.contraindication", "min": 0, "definition": "Specifics for when this is a contraindication.", "isModifier": false, "short": "Specifics for when this is a contraindication", "mapping": [ { "map": "Contraindication", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "0", "id": "ClinicalUseDefinition.contraindication", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.contraindication" }, "isSummary": true }, { "path": "ClinicalUseDefinition.contraindication.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.contraindication.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.contraindication.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.contraindication.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.contraindication.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.contraindication.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.contraindication.diseaseSymptomProcedure", "min": 0, "definition": "The situation that is being documented as contraindicating against this item.", "isModifier": false, "short": "The situation that is being documented as contraindicating against this item", "mapping": [ { "map": "Contraindication.Contraindications as \"Disease / Symptom / Procedure\" and Contraindication.Contraindications Text", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-symptom-procedure", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseSymptomProcedure" } ], "description": "A symptom, disease or procedure." }, "max": "1", "id": "ClinicalUseDefinition.contraindication.diseaseSymptomProcedure", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.contraindication.diseaseSymptomProcedure" }, "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": "ClinicalUseDefinition.contraindication.diseaseStatus", "min": 0, "definition": "The status of the disease or symptom for the contraindication, for example \"chronic\" or \"metastatic\".", "isModifier": false, "short": "The status of the disease or symptom for the contraindication", "mapping": [ { "map": "Contraindication.Disease Status", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-status", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseStatus" } ], "description": "The status of a disease or symptom." }, "max": "1", "id": "ClinicalUseDefinition.contraindication.diseaseStatus", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.contraindication.diseaseStatus" }, "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": "ClinicalUseDefinition.contraindication.comorbidity", "min": 0, "definition": "A comorbidity (concurrent condition) or coinfection.", "isModifier": false, "short": "A comorbidity (concurrent condition) or coinfection", "mapping": [ { "map": "Contraindication.Comorbidity", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-symptom-procedure", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseSymptomProcedure" } ], "description": "A symptom, disease or procedure." }, "max": "*", "id": "ClinicalUseDefinition.contraindication.comorbidity", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.contraindication.comorbidity" }, "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": "ClinicalUseDefinition.contraindication.indication", "min": 0, "definition": "The indication which this is a contraidication for.", "isModifier": false, "short": "The indication which this is a contraidication for", "mapping": [ { "map": "(the link from Contraindication to Therapeutic Indication)", "identity": "idmp" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" ] } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.contraindication.indication", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.contraindication.indication" }, "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": "ClinicalUseDefinition.contraindication.otherTherapy", "min": 0, "definition": "Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.", "isModifier": false, "short": "Information about use of the product in relation to other therapies described as part of the contraindication", "mapping": [ { "map": "Contraindication.Other Therapy Specifics", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.contraindication.otherTherapy", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.contraindication.otherTherapy" }, "isSummary": true }, { "path": "ClinicalUseDefinition.contraindication.otherTherapy.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.contraindication.otherTherapy.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.contraindication.otherTherapy.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.contraindication.otherTherapy.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.contraindication.otherTherapy.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.contraindication.otherTherapy.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.contraindication.otherTherapy.relationshipType", "min": 1, "definition": "The type of relationship between the medicinal product indication or contraindication and another therapy.", "isModifier": false, "short": "The type of relationship between the product indication/contraindication and another therapy", "mapping": [ { "map": "Other Therapy Specifics.Therapy Relationship Type", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/therapy-relationship-type", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "TherapyRelationshipType" } ], "description": "Classification of relationship between a therapy and a contraindication or an indication." }, "max": "1", "id": "ClinicalUseDefinition.contraindication.otherTherapy.relationshipType", "base": { "max": "1", "min": 1, "path": "ClinicalUseDefinition.contraindication.otherTherapy.relationshipType" }, "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": "ClinicalUseDefinition.contraindication.otherTherapy.treatment", "min": 1, "definition": "Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication.", "isModifier": false, "short": "Reference to a specific medication as part of an indication or contraindication", "mapping": [ { "map": "Other Therapy Specifics.Medication", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition", "http://hl7.org/fhir/StructureDefinition/ActivityDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/therapy", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Therapy" } ], "description": "A therapy." }, "max": "1", "id": "ClinicalUseDefinition.contraindication.otherTherapy.treatment", "base": { "max": "1", "min": 1, "path": "ClinicalUseDefinition.contraindication.otherTherapy.treatment" }, "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": "ClinicalUseDefinition.indication", "min": 0, "definition": "Specifics for when this is an indication.", "isModifier": false, "short": "Specifics for when this is an indication", "mapping": [ { "map": "Therapeutic Indication", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "0", "id": "ClinicalUseDefinition.indication", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.indication" }, "isSummary": true }, { "path": "ClinicalUseDefinition.indication.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.indication.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.indication.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.indication.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.indication.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.indication.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.indication.diseaseSymptomProcedure", "min": 0, "definition": "The situation that is being documented as an indicaton for this item.", "isModifier": false, "short": "The situation that is being documented as an indicaton for this item", "mapping": [ { "map": "Therapeutic Indication.Indication as \"Disease / Symptom / Procedure\", and Therapeutic Indication.Indication Text", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-symptom-procedure", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseSymptomProcedure" } ], "description": "A symptom, disease or procedure." }, "max": "1", "id": "ClinicalUseDefinition.indication.diseaseSymptomProcedure", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.indication.diseaseSymptomProcedure" }, "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": "ClinicalUseDefinition.indication.diseaseStatus", "min": 0, "definition": "The status of the disease or symptom for the indication, for example \"chronic\" or \"metastatic\".", "isModifier": false, "short": "The status of the disease or symptom for the indication", "mapping": [ { "map": "Therapeutic Indication.Disease Status", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-status", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseStatus" } ], "description": "The status of a disease or symptom." }, "max": "1", "id": "ClinicalUseDefinition.indication.diseaseStatus", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.indication.diseaseStatus" }, "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": "ClinicalUseDefinition.indication.comorbidity", "min": 0, "definition": "A comorbidity (concurrent condition) or coinfection as part of the indication.", "isModifier": false, "short": "A comorbidity or coinfection as part of the indication", "mapping": [ { "map": "Therapeutic Indication.Comorbidity", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/disease-symptom-procedure", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "DiseaseSymptomProcedure" } ], "description": "A symptom, disease or procedure." }, "max": "*", "id": "ClinicalUseDefinition.indication.comorbidity", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.indication.comorbidity" }, "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": "ClinicalUseDefinition.indication.intendedEffect", "min": 0, "definition": "The intended effect, aim or strategy to be achieved.", "isModifier": false, "short": "The intended effect, aim or strategy to be achieved", "mapping": [ { "map": "Therapeutic Indication.Intended Effect", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/product-intended-use", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductIntendedUse" } ], "description": "The overall intended use of a product." }, "max": "1", "id": "ClinicalUseDefinition.indication.intendedEffect", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.indication.intendedEffect" }, "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": "ClinicalUseDefinition.indication.duration[x]", "min": 0, "definition": "Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).", "isModifier": false, "short": "Timing or duration information", "mapping": [ { "map": "Therapeutic Indication.Timing / Duration", "identity": "idmp" } ], "type": [ { "code": "Range" }, { "code": "string" } ], "mustSupport": false, "max": "1", "id": "ClinicalUseDefinition.indication.duration[x]", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.indication.duration[x]" }, "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": "ClinicalUseDefinition.indication.undesirableEffect", "min": 0, "definition": "An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.", "isModifier": false, "short": "An unwanted side effect or negative outcome of the subject of this resource when being used for this indication", "mapping": [ { "map": "Therapeutic Indication.Undesirable Effects", "identity": "idmp" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" ] } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.indication.undesirableEffect", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.indication.undesirableEffect" }, "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": "ClinicalUseDefinition.indication.otherTherapy", "min": 0, "definition": "Information about the use of the medicinal product in relation to other therapies described as part of the indication.", "isModifier": false, "short": "The use of the medicinal product in relation to other therapies described as part of the indication", "mapping": [ { "map": "Therapeutic Indication.Other Therapy Specifics", "identity": "idmp" } ], "contentReference": "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition#ClinicalUseDefinition.contraindication.otherTherapy", "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.indication.otherTherapy", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.indication.otherTherapy" }, "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": "ClinicalUseDefinition.interaction", "min": 0, "definition": "Specifics for when this is an interaction.", "isModifier": false, "short": "Specifics for when this is an interaction", "mapping": [ { "map": "Interactions", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "0", "id": "ClinicalUseDefinition.interaction", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.interaction" }, "isSummary": true }, { "path": "ClinicalUseDefinition.interaction.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.interaction.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.interaction.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.interaction.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.interaction.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.interaction.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.interaction.interactant", "min": 0, "definition": "The specific medication, food, substance or laboratory test that interacts.", "isModifier": false, "short": "The specific medication, food, substance or laboratory test that interacts", "mapping": [ { "map": "Interactions.Interactant and Interactions.Interactions Text", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.interaction.interactant", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.interaction.interactant" }, "isSummary": true }, { "path": "ClinicalUseDefinition.interaction.interactant.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.interaction.interactant.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.interaction.interactant.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.interaction.interactant.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.interaction.interactant.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.interaction.interactant.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.interaction.interactant.item[x]", "min": 1, "definition": "The specific medication, food or laboratory test that interacts.", "isModifier": false, "short": "The specific medication, food or laboratory test that interacts", "mapping": [ { "map": "Interactions.Interactant and Interactions.Interactions Text", "identity": "idmp" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] }, { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/interactant", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Interactant" } ], "description": "An interactant - a substance that may have an clinically significant effect on another." }, "max": "1", "id": "ClinicalUseDefinition.interaction.interactant.item[x]", "base": { "max": "1", "min": 1, "path": "ClinicalUseDefinition.interaction.interactant.item[x]" }, "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": "ClinicalUseDefinition.interaction.type", "min": 0, "definition": "The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.", "isModifier": false, "short": "The type of the interaction e.g. drug-drug interaction, drug-lab test interaction", "mapping": [ { "map": "Interactions.Interactions Type", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/interaction-type", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "InteractionType" } ], "description": "A categorisation for an interaction between two substances." }, "max": "1", "id": "ClinicalUseDefinition.interaction.type", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.interaction.type" }, "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": "ClinicalUseDefinition.interaction.effect", "min": 0, "definition": "The effect of the interaction, for example \"reduced gastric absorption of primary medication\".", "isModifier": false, "short": "The effect of the interaction, for example \"reduced gastric absorption of primary medication\"", "mapping": [ { "map": "Interactions.Interactions Effect", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/interaction-effect", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "InteractionEffect" } ], "description": "A interaction effect of clinical use of a medication or other substance." }, "max": "1", "id": "ClinicalUseDefinition.interaction.effect", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.interaction.effect" }, "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": "ClinicalUseDefinition.interaction.incidence", "min": 0, "definition": "The incidence of the interaction, e.g. theoretical, observed.", "isModifier": false, "short": "The incidence of the interaction, e.g. theoretical, observed", "mapping": [ { "map": "Interactions.Interactions Incidence", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/interaction-incidence", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "UndesirableEffectSymptom" } ], "description": "A categorisation for incidence of occurence of an interaction." }, "max": "1", "id": "ClinicalUseDefinition.interaction.incidence", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.interaction.incidence" }, "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": "ClinicalUseDefinition.interaction.management", "min": 0, "definition": "Actions for managing the interaction.", "isModifier": false, "short": "Actions for managing the interaction", "mapping": [ { "map": "Interactions.Management Actions", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/interaction-management", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "InteractionManagement" } ], "description": "A type of management for an interaction of a medication or other substance." }, "max": "*", "id": "ClinicalUseDefinition.interaction.management", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.interaction.management" }, "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": "ClinicalUseDefinition.population", "min": 0, "definition": "The population group to which this applies.", "isModifier": false, "short": "The population group to which this applies", "mapping": [ { "map": "Population Specifics", "identity": "idmp" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ] } ], "mustSupport": false, "max": "*", "id": "ClinicalUseDefinition.population", "base": { "max": "*", "min": 0, "path": "ClinicalUseDefinition.population" }, "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": "ClinicalUseDefinition.undesirableEffect", "min": 1, "definition": "Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.", "isModifier": false, "short": "A possible negative outcome from the use of this treatment", "mapping": [ { "map": "Undesirable Effects", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "1", "id": "ClinicalUseDefinition.undesirableEffect", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.undesirableEffect" }, "isSummary": true }, { "path": "ClinicalUseDefinition.undesirableEffect.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.undesirableEffect.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.undesirableEffect.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.undesirableEffect.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.undesirableEffect.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.undesirableEffect.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "min": 0, "definition": "The situation in which the undesirable effect may manifest.", "isModifier": false, "short": "The situation in which the undesirable effect may manifest.", "mapping": [ { "map": "Undesirable Effects.Undesirable Effect as \"Symptom / Condition / Effect\"", "identity": "idmp" } ], "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/undesirable-effect-symptom", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "UndesirableEffectSymptom" } ], "description": "An undesirable effect of clinical use." }, "max": "1", "id": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect" }, "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": "ClinicalUseDefinition.undesirableEffect.classification", "min": 0, "definition": "High level classification of the effect.", "isModifier": false, "short": "High level classification of the effect.", "mapping": [ { "map": "Undesirable Effects.Symptom / Condition / Effect Classification", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/undesirable-effect-classification", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "UndesirableEffectClassification" } ], "description": "A categorisation for an undesirable effect." }, "max": "1", "id": "ClinicalUseDefinition.undesirableEffect.classification", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.undesirableEffect.classification" }, "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": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "min": 0, "definition": "How often the effect is seen.", "isModifier": false, "short": "How often the effect is seen.", "mapping": [ { "map": "Undesirable Effects.Frequency of Occurrence", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/undesirable-effect-frequency", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "UndesirablEffectFrequency" } ], "description": "A categorisation for a frequency of occurence of an undesirable effect." }, "max": "1", "id": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence" }, "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": "ClinicalUseDefinition.warning", "min": 0, "definition": "A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.", "isModifier": false, "short": "Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'", "mapping": [ { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "max": "0", "id": "ClinicalUseDefinition.warning", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.warning" }, "isSummary": true }, { "path": "ClinicalUseDefinition.warning.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "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": "ClinicalUseDefinition.warning.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "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": "ClinicalUseDefinition.warning.extension", "min": 0, "definition": "May be 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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "ClinicalUseDefinition.warning.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "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": "ClinicalUseDefinition.warning.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://build.fhir.org/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" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content", "modifiers" ], "max": "*", "id": "ClinicalUseDefinition.warning.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", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "ClinicalUseDefinition.warning.description", "min": 0, "definition": "A textual definition of this warning, with formatting.", "isModifier": false, "short": "A textual definition of this warning, with formatting", "mapping": [ { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "markdown" } ], "mustSupport": false, "max": "1", "id": "ClinicalUseDefinition.warning.description", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.warning.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": "ClinicalUseDefinition.warning.code", "min": 0, "definition": "A coded or unformatted textual definition of this warning.", "isModifier": false, "short": "A coded or unformatted textual definition of this warning", "mapping": [ { "map": "n/a", "identity": "idmp" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "binding": { "strength": "example", "valueSet": "http://hl7.org/fhir/ValueSet/warning-type", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "WarningType" } ], "description": "Classification of warning type." }, "max": "1", "id": "ClinicalUseDefinition.warning.code", "base": { "max": "1", "min": 0, "path": "ClinicalUseDefinition.warning.code" }, "isSummary": true } ] }, "status": "active", "id": "e7788e5b-d676-4de1-8882-070c6ede1735", "kind": "resource", "url": "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi", "version": "1.0.0-ballot", "differential": { "element": [ { "id": "ClinicalUseDefinition", "path": "ClinicalUseDefinition" }, { "id": "ClinicalUseDefinition.identifier", "path": "ClinicalUseDefinition.identifier", "short": "Business identifier for this clinical use." }, { "id": "ClinicalUseDefinition.type", "path": "ClinicalUseDefinition.type", "patternCode": "undesirable-effect" }, { "id": "ClinicalUseDefinition.subject", "min": 1, "path": "ClinicalUseDefinition.subject", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi" ] } ] }, { "id": "ClinicalUseDefinition.status", "path": "ClinicalUseDefinition.status", "short": "Defines whether this clinical use is draft, active or retired" }, { "id": "ClinicalUseDefinition.contraindication", "max": "0", "path": "ClinicalUseDefinition.contraindication" }, { "id": "ClinicalUseDefinition.indication", "max": "0", "path": "ClinicalUseDefinition.indication" }, { "id": "ClinicalUseDefinition.interaction", "max": "0", "path": "ClinicalUseDefinition.interaction" }, { "id": "ClinicalUseDefinition.undesirableEffect", "min": 1, "path": "ClinicalUseDefinition.undesirableEffect" }, { "id": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "path": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "short": "The situation in which the undesirable effect may manifest." }, { "id": "ClinicalUseDefinition.undesirableEffect.classification", "path": "ClinicalUseDefinition.undesirableEffect.classification", "short": "High level classification of the effect." }, { "id": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "path": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "short": "How often the effect is seen." }, { "id": "ClinicalUseDefinition.warning", "max": "0", "path": "ClinicalUseDefinition.warning" } ] }, "contact": [ { "name": "HL7 BR&R", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" }