Extensions for Using Data Elements from FHIR R4B in FHIR R5 - Downloaded Version null See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON
• TTL

Resource Profile: Profile_R4B_RegulatedAuthorization_R5

This cross-version profile allows R4B RegulatedAuthorization content to be represented via FHIR R5 RegulatedAuthorization resources.

Usages:

• This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	RegulatedAuthorization.implicitRules, RegulatedAuthorization.modifierExtension	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	RegulatedAuthorization.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned
validityPeriod	Σ	0..1	Period	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​language	Base	required	All Languages	📍5.0.0	FHIR Std.
RegulatedAuthorization.​type	Base	example	Regulated Authorization Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​region	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
RegulatedAuthorization.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
RegulatedAuthorization.​intendedUse	Base	preferred	Product Intended Use	📍5.0.0	FHIR Std.
RegulatedAuthorization.​basis	Base	example	Regulated Authorization Basis	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.type	Base	example	Regulated Authorization Case Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	RegulatedAuthorization.meta, RegulatedAuthorization.implicitRules, RegulatedAuthorization.language, RegulatedAuthorization.text, RegulatedAuthorization.extension, RegulatedAuthorization.modifierExtension, RegulatedAuthorization.identifier, RegulatedAuthorization.subject, RegulatedAuthorization.type, RegulatedAuthorization.description, RegulatedAuthorization.region, RegulatedAuthorization.status, RegulatedAuthorization.statusDate, RegulatedAuthorization.validityPeriod, RegulatedAuthorization.indication, RegulatedAuthorization.intendedUse, RegulatedAuthorization.basis, RegulatedAuthorization.holder, RegulatedAuthorization.regulator, RegulatedAuthorization.attachedDocument, RegulatedAuthorization.case, RegulatedAuthorization.case.extension, RegulatedAuthorization.case.modifierExtension, RegulatedAuthorization.case.identifier, RegulatedAuthorization.case.type, RegulatedAuthorization.case.status, RegulatedAuthorization.case.date[x], RegulatedAuthorization.case.application	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	RegulatedAuthorization.extension, RegulatedAuthorization.modifierExtension, RegulatedAuthorization.case.extension, RegulatedAuthorization.case.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Maturity: 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	RegulatedAuthorization.implicitRules, RegulatedAuthorization.modifierExtension	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	RegulatedAuthorization.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential View

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
RegulatedAuthorization		0..*	RegulatedAuthorization(5.0.0)	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned
validityPeriod	Σ	0..1	Period	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​language	Base	required	All Languages	📍5.0.0	FHIR Std.
RegulatedAuthorization.​type	Base	example	Regulated Authorization Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​region	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
RegulatedAuthorization.​status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
RegulatedAuthorization.​intendedUse	Base	preferred	Product Intended Use	📍5.0.0	FHIR Std.
RegulatedAuthorization.​basis	Base	example	Regulated Authorization Basis	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.type	Base	example	Regulated Authorization Case Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	RegulatedAuthorization.meta, RegulatedAuthorization.implicitRules, RegulatedAuthorization.language, RegulatedAuthorization.text, RegulatedAuthorization.extension, RegulatedAuthorization.modifierExtension, RegulatedAuthorization.identifier, RegulatedAuthorization.subject, RegulatedAuthorization.type, RegulatedAuthorization.description, RegulatedAuthorization.region, RegulatedAuthorization.status, RegulatedAuthorization.statusDate, RegulatedAuthorization.validityPeriod, RegulatedAuthorization.indication, RegulatedAuthorization.intendedUse, RegulatedAuthorization.basis, RegulatedAuthorization.holder, RegulatedAuthorization.regulator, RegulatedAuthorization.attachedDocument, RegulatedAuthorization.case, RegulatedAuthorization.case.extension, RegulatedAuthorization.case.modifierExtension, RegulatedAuthorization.case.identifier, RegulatedAuthorization.case.type, RegulatedAuthorization.case.status, RegulatedAuthorization.case.date[x], RegulatedAuthorization.case.application	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	RegulatedAuthorization.extension, RegulatedAuthorization.modifierExtension, RegulatedAuthorization.case.extension, RegulatedAuthorization.case.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Maturity: 0

Other representations of profile: CSV, Excel, Schematron