FHIR IG analytics| Package | hl7.fhir.uv.xver-r5.r4b |
| Resource Type | StructureDefinition |
| Id | StructureDefinition-profile-RegulatedAuthorization.json |
| FHIR Version | R4B |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition profile-RegulatedAuthorization
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  RegulatedAuthorization | 0..* | RegulatedAuthorization(4.3.0) | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
   extension:attachedDocument | 0..* | Reference(Cross-version Profile for R5.DocumentReference for use in FHIR R4B(0.1.0) | Media) | R5: Additional information or supporting documentation about the authorization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-RegulatedAuthorization.attachedDocument | |
  subject | ||||
 Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:subject | 0..* | Reference(Resource) | R5: subject URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |
| Documentation for this format | ||||
FHIR
FHIRsmith{
"resourceType": "StructureDefinition",
"id": "profile-RegulatedAuthorization",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "fhir"
},
{
"extension": [
{
"url": "packageId",
"valueId": "hl7.fhir.uv.xver-r5.r4b"
},
{
"url": "version",
"valueString": "0.1.0"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/package-source"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0,
"_valueInteger": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4b"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4b"
}
]
}
}
],
"url": "http://hl7.org/fhir/5.0/StructureDefinition/profile-RegulatedAuthorization",
"version": "0.1.0",
"name": "Profile_R5_RegulatedAuthorization_R4B",
"title": "Cross-version Profile for R5.RegulatedAuthorization for use in FHIR R4B",
"status": "active",
"experimental": false,
"date": "2026-03-17T16:03:55.0506793-05:00",
"publisher": "FHIR Infrastructure",
"contact": [
{
"name": "FHIR Infrastructure",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/fiwg"
}
]
}
],
"description": "This cross-version profile allows R5 RegulatedAuthorization content to be represented via FHIR R4B RegulatedAuthorization resources.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"fhirVersion": "4.3.0",
"mapping": [
{
"identity": "idmp",
"uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products",
"name": "IDMP Mapping"
},
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "RegulatedAuthorization",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.3.0"
}
],
"element": [
{
"id": "RegulatedAuthorization",
"path": "RegulatedAuthorization",
"short": "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product",
"definition": "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization",
"min": 0,
"max": "*"
},
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"xpath": "not(parent::f:contained and f:contained)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"
},
{
"key": "dom-3",
"severity": "error",
"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",
"expression": "contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()",
"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|4.3.0"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"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|4.3.0"
},
{
"key": "dom-5",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression": "contained.meta.security.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:security))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"
},
{
"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."
}
],
"key": "dom-6",
"severity": "warning",
"human": "A resource should have narrative for robust management",
"expression": "text.`div`.exists()",
"xpath": "exists(f:text/h:div)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
},
{
"identity": "idmp",
"map": "Marketing Authorisation, Clinical Trial Authorisation"
},
{
"identity": "w5",
"map": "administrative.medication"
}
]
},
{
"id": "RegulatedAuthorization.id",
"path": "RegulatedAuthorization.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true
},
{
"id": "RegulatedAuthorization.meta",
"path": "RegulatedAuthorization.meta",
"short": "Metadata about the resource",
"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.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true
},
{
"id": "RegulatedAuthorization.implicitRules",
"path": "RegulatedAuthorization.implicitRules",
"short": "A set of rules under which this content was created",
"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.",
"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.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": true,
"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
},
{
"id": "RegulatedAuthorization.language",
"path": "RegulatedAuthorization.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"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).",
"min": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical": "http://hl7.org/fhir/ValueSet/all-languages|4.3.0"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
}
],
"strength": "preferred",
"description": "IETF language tag",
"valueSet": "http://hl7.org/fhir/ValueSet/languages|4.3.0"
}
},
{
"id": "RegulatedAuthorization.text",
"path": "RegulatedAuthorization.text",
"short": "Text summary of the resource, for human interpretation",
"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.",
"comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "RegulatedAuthorization.contained",
"path": "RegulatedAuthorization.contained",
"short": "Contained, inline Resources",
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"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.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"constraint": [
{
"key": "dom-r4b",
"severity": "warning",
"human": "Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems",
"expression": "($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)",
"xpath": "not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:PackagedProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedAuthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citation|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDefinition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingredient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic)",
"source": "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.extension",
"path": "RegulatedAuthorization.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "RegulatedAuthorization.extension:attachedDocument",
"path": "RegulatedAuthorization.extension",
"sliceName": "attachedDocument",
"short": "R5: Additional information or supporting documentation about the authorization (new)",
"definition": "R5: `RegulatedAuthorization.attachedDocument` (new:Reference(DocumentReference))",
"comment": "Element `RegulatedAuthorization.attachedDocument` has a context of RegulatedAuthorization based on following the parent source element upwards and mapping to `RegulatedAuthorization`.\nElement `RegulatedAuthorization.attachedDocument` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/5.0/StructureDefinition/extension-RegulatedAuthorization.attachedDocument|0.1.0"
]
}
],
"condition": [
"ele-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression": "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath": "@value|f:*|h:div|self::f:Parameters",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": false
},
{
"id": "RegulatedAuthorization.modifierExtension",
"path": "RegulatedAuthorization.modifierExtension",
"short": "Extensions that cannot be ignored",
"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).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"mustSupport": false,
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.identifier",
"path": "RegulatedAuthorization.identifier",
"short": "Business identifier for the authorization, typically assigned by the authorizing body",
"definition": "Business identifier for the authorization, typically assigned by the authorizing body.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization.identifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Identifier"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Marketing Authorisation Number"
}
]
},
{
"id": "RegulatedAuthorization.subject",
"path": "RegulatedAuthorization.subject",
"short": "The product type, treatment, facility or activity that is being authorized",
"definition": "The product type, treatment, facility or activity that is being authorized.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization.subject",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct|4.3.0",
"http://hl7.org/fhir/StructureDefinition/NutritionProduct|4.3.0",
"http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/SubstanceDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.3.0",
"http://hl7.org/fhir/StructureDefinition/ActivityDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/PlanDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/ObservationDefinition|4.3.0",
"http://hl7.org/fhir/StructureDefinition/Practitioner|4.3.0",
"http://hl7.org/fhir/StructureDefinition/Organization|4.3.0",
"http://hl7.org/fhir/StructureDefinition/Location|4.3.0"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "(the link to Medicinal Product or Packaged Medicinal Product)"
}
]
},
{
"id": "RegulatedAuthorization.subject.id",
"path": "RegulatedAuthorization.subject.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.subject.extension",
"path": "RegulatedAuthorization.subject.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "RegulatedAuthorization.subject.extension:subject",
"path": "RegulatedAuthorization.subject.extension",
"sliceName": "subject",
"short": "R5: subject",
"definition": "R5: `RegulatedAuthorization.subject`",
"comment": "Element `RegulatedAuthorization.subject` is mapped to FHIR R4B element `RegulatedAuthorization.subject` as `SourceIsBroaderThanTarget`.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `RegulatedAuthorization.subject` with unmapped reference targets: Ingredient, ManufacturedItemDefinition, NutritionProduct.",
"min": 0,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "RegulatedAuthorization.subject.reference",
"path": "RegulatedAuthorization.subject.reference",
"short": "Literal reference, Relative, internal or absolute URL",
"definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.",
"comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.reference",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"condition": [
"ref-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.subject.type",
"path": "RegulatedAuthorization.subject.type",
"short": "Type the reference refers to (e.g. \"Patient\")",
"definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).",
"comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/build/StructureDefinition/binding-definition",
"valueString": "Aa resource (or, for logical models, the URI of the logical model)."
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "FHIRResourceTypeExt"
}
],
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/resource-types|4.3.0"
},
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.subject.identifier",
"path": "RegulatedAuthorization.subject.identifier",
"short": "Logical reference, when literal reference is not known",
"definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.",
"comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).",
"min": 0,
"max": "1",
"base": {
"path": "Reference.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "RegulatedAuthorization.subject.display",
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}
],
"path": "RegulatedAuthorization.subject.display",
"short": "Text alternative for the resource",
"definition": "Plain text narrative that identifies the resource in addition to the resource reference.",
"comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.",
"min": 0,
"max": "1",
"base": {
"path": "Reference.display",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.type",
"path": "RegulatedAuthorization.type",
"short": "Overall type of this authorization, for example drug marketing approval, orphan drug designation",
"definition": "Overall type of this authorization, for example drug marketing approval, orphan drug designation.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RegulatedAuthorizationType"
}
],
"strength": "example",
"description": "Overall type of this authorization.",
"valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-type|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.description",
"path": "RegulatedAuthorization.description",
"short": "General textual supporting information",
"definition": "General textual supporting information.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.region",
"path": "RegulatedAuthorization.region",
"short": "The territory in which the authorization has been granted",
"definition": "The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization.region",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
}
],
"strength": "example",
"description": "Jurisdiction codes",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Country"
}
]
},
{
"id": "RegulatedAuthorization.status",
"path": "RegulatedAuthorization.status",
"short": "The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications",
"definition": "The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.status",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
}
],
"strength": "preferred",
"description": "The lifecycle status of an artifact.",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Authorisation Status"
}
]
},
{
"id": "RegulatedAuthorization.statusDate",
"path": "RegulatedAuthorization.statusDate",
"short": "The date at which the current status was assigned",
"definition": "The date at which the current status was assigned.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.statusDate",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Authorisation Status Date"
}
]
},
{
"id": "RegulatedAuthorization.validityPeriod",
"path": "RegulatedAuthorization.validityPeriod",
"short": "The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date",
"definition": "The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.validityPeriod",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End"
}
]
},
{
"id": "RegulatedAuthorization.indication",
"path": "RegulatedAuthorization.indication",
"short": "Condition for which the use of the regulated product applies",
"definition": "Condition for which the use of the regulated product applies.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.indication",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableReference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition|4.3.0"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.intendedUse",
"path": "RegulatedAuthorization.intendedUse",
"short": "The intended use of the product, e.g. prevention, treatment",
"definition": "The intended use of the product, e.g. prevention, treatment, diagnosis.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.intendedUse",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ProductIntendedUse"
}
],
"strength": "preferred",
"description": "The overall intended use of a product.",
"valueSet": "http://hl7.org/fhir/ValueSet/product-intended-use|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.basis",
"path": "RegulatedAuthorization.basis",
"short": "The legal/regulatory framework or reasons under which this authorization is granted",
"definition": "The legal or regulatory framework against which this authorization is granted, or other reasons for it.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization.basis",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RegulatedAuthorizationBasis"
}
],
"strength": "example",
"description": "A legal or regulatory framework against which an authorization is granted, or other reasons for it.",
"valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-basis|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Status Reasons.Legal Grounds"
}
]
},
{
"id": "RegulatedAuthorization.holder",
"path": "RegulatedAuthorization.holder",
"short": "The organization that has been granted this authorization, by the regulator",
"definition": "The organization that has been granted this authorization, by some authoritative body (the 'regulator').",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.holder",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization|4.3.0"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Marketing Authorisation Holder (Organisation)"
}
]
},
{
"id": "RegulatedAuthorization.regulator",
"path": "RegulatedAuthorization.regulator",
"short": "The regulatory authority or authorizing body granting the authorization",
"definition": "The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.regulator",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization|4.3.0"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Medicines Regulatory Agency (Organisation)"
}
]
},
{
"id": "RegulatedAuthorization.case",
"path": "RegulatedAuthorization.case",
"short": "The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)",
"definition": "The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.case",
"min": 0,
"max": "1"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression": "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath": "@value|f:*|h:div|self::f:Parameters",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketing Authorisation Application"
}
]
},
{
"id": "RegulatedAuthorization.case.id",
"path": "RegulatedAuthorization.case.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.case.extension",
"path": "RegulatedAuthorization.case.extension",
"short": "Additional content defined by implementations",
"definition": "May be 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.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.case.modifierExtension",
"path": "RegulatedAuthorization.case.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"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).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "RegulatedAuthorization.case.identifier",
"path": "RegulatedAuthorization.case.identifier",
"short": "Identifier by which this case can be referenced",
"definition": "Identifier by which this case can be referenced.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.case.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number"
}
]
},
{
"id": "RegulatedAuthorization.case.type",
"path": "RegulatedAuthorization.case.type",
"short": "The defining type of case",
"definition": "The defining type of case.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.case.type",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "RegulatedAuthorizationCaseType"
}
],
"strength": "example",
"description": "The type of a case involved in an application.",
"valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type"
}
]
},
{
"id": "RegulatedAuthorization.case.status",
"path": "RegulatedAuthorization.case.status",
"short": "The status associated with the case",
"definition": "The status associated with the case.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.case.status",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "PublicationStatus"
}
],
"strength": "preferred",
"description": "The lifecycle status of an artifact.",
"valueSet": "http://hl7.org/fhir/ValueSet/publication-status|4.3.0"
},
"mapping": [
{
"identity": "idmp",
"map": "n/a"
}
]
},
{
"id": "RegulatedAuthorization.case.date[x]",
"path": "RegulatedAuthorization.case.date[x]",
"short": "Relevant date for this case",
"definition": "Relevant date for this case.",
"min": 0,
"max": "1",
"base": {
"path": "RegulatedAuthorization.case.date[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
},
{
"code": "dateTime"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date"
}
]
},
{
"id": "RegulatedAuthorization.case.application",
"path": "RegulatedAuthorization.case.application",
"short": "Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure",
"definition": "A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.",
"min": 0,
"max": "*",
"base": {
"path": "RegulatedAuthorization.case.application",
"min": 0,
"max": "*"
},
"contentReference": "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case",
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element|4.3.0"
}
],
"mustSupport": false,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "idmp",
"map": "Marketing Authorisation.Marketing Authorisation Application"
}
]
}
]
},
"differential": {
"element": [
{
"id": "RegulatedAuthorization",
"path": "RegulatedAuthorization"
},
{
"id": "RegulatedAuthorization.extension",
"path": "RegulatedAuthorization.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "RegulatedAuthorization.extension:attachedDocument",
"path": "RegulatedAuthorization.extension",
"sliceName": "attachedDocument",
"short": "R5: Additional information or supporting documentation about the authorization (new)",
"definition": "R5: `RegulatedAuthorization.attachedDocument` (new:Reference(DocumentReference))",
"comment": "Element `RegulatedAuthorization.attachedDocument` has a context of RegulatedAuthorization based on following the parent source element upwards and mapping to `RegulatedAuthorization`.\nElement `RegulatedAuthorization.attachedDocument` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/5.0/StructureDefinition/extension-RegulatedAuthorization.attachedDocument|0.1.0"
]
}
]
},
{
"id": "RegulatedAuthorization.subject.extension",
"path": "RegulatedAuthorization.subject.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 0,
"max": "*"
},
{
"id": "RegulatedAuthorization.subject.extension:subject",
"path": "RegulatedAuthorization.subject.extension",
"sliceName": "subject",
"short": "R5: subject",
"definition": "R5: `RegulatedAuthorization.subject`",
"comment": "Element `RegulatedAuthorization.subject` is mapped to FHIR R4B element `RegulatedAuthorization.subject` as `SourceIsBroaderThanTarget`.\nThe standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `RegulatedAuthorization.subject` with unmapped reference targets: Ingredient, ManufacturedItemDefinition, NutritionProduct.",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"
]
}
]
}
]
}
}