0.1.0 - ci-build

EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EU AI Act Model Card

Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-model-card Version: 0.1.0
Draft as of 2026-06-18 Computable Name: EU_AIModelCard

A DocumentReference profile representing technical documentation about an AI system, such as intended use, limitations, risk-related information, performance-related information, and model documentation.

Usages:

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.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... status ?!SΣ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... type SΣ 1..1 CodeableConcept AI Model Card
Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(EU AI System Device) Reference to the specific AI System Device (Traceability)
... context C 0..* Reference(Appointment | Encounter | EpisodeOfCare) Context of the document content
... description SΣ 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... content SΣ 1..* BackboneElement Document referenced
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment SΣ 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... contentType SΣC 1..1 code Mime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
Example General: text/plain; charset=UTF-8, image/png
..... data SC 0..1 base64Binary Data inline, base64ed
..... url SΣ 0..1 url Uri where the data can be found
Example General: http://www.acme.com/logo-small.png
..... title SΣ 1..1 string Label to display in place of the data
Example General: Official Corporate Logo

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.status Base required DocumentReferenceStatus 📍5.0.0 FHIR Std.
DocumentReference.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.contentType Base required Mime Types 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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 DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from DocumentReference

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference 0..* DocumentReference A reference to a document
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... status S 1..1 code current | superseded | entered-in-error
... type S 1..1 CodeableConcept AI Model Card
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
... description S 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... content S 1..* BackboneElement Document referenced
.... attachment S 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... contentType S 1..1 code Mime type of the content, with charset etc.
..... data S 0..1 base64Binary Data inline, base64ed
..... url S 0..1 url Uri where the data can be found
..... title S 1..1 string Label to display in place of the data

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... 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 BindingsPurpose
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
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifiers for the document
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the DocumentReference
... basedOn 0..* Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription) Procedure that caused this media to be created
... status ?!SΣ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... docStatus Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... modality Σ 0..* CodeableConcept Imaging modality used
Binding: Modality . (extensible): Type of acquired data in the instance.
... type SΣ 1..1 CodeableConcept AI Model Card
Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of document
Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
... subject SΣ 1..1 Reference(EU AI System Device) Reference to the specific AI System Device (Traceability)
... context C 0..* Reference(Appointment | Encounter | EpisodeOfCare) Context of the document content
... event 0..* CodeableReference() Main clinical acts documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... bodySite Σ 0..* CodeableReference(BodyStructure) Body part included
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... facilityType C 0..1 CodeableConcept Kind of facility where patient was seen
Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
... practiceSetting C 0..1 CodeableConcept Additional details about where the content was created (e.g. clinical specialty)
Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
... period Σ 0..1 Period Time of service that is being documented
... date Σ 0..1 instant When this document reference was created
... author Σ 0..* Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam) Who and/or what authored the document
... attester 0..* BackboneElement Attests to accuracy of the document
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a document.
.... time 0..1 dateTime When the document was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the document
... custodian 0..1 Reference(Organization) Organization which maintains the document
... relatesTo Σ 0..* BackboneElement Relationships to other documents
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept The relationship type with another document
Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
.... target Σ 1..1 Reference(DocumentReference) Target of the relationship
... description SΣ 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... securityLabel Σ 0..* CodeableConcept Document security-tags
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
... content SΣ 1..* BackboneElement Document referenced
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment SΣ 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... contentType SΣC 1..1 code Mime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
Example General: text/plain; charset=UTF-8, image/png
..... language Σ 0..1 code Human language of the content (BCP-47)
Binding: AllLanguages (required): IETF language tag for a human language.
Additional BindingsPurpose
CommonLanguages Starter

Example General: en-AU
..... data SC 0..1 base64Binary Data inline, base64ed
..... url SΣ 0..1 url Uri where the data can be found
Example General: http://www.acme.com/logo-small.png
..... size Σ 0..1 integer64 Number of bytes of content (if url provided)
..... hash Σ 0..1 base64Binary Hash of the data (sha-1, base64ed)
..... title SΣ 1..1 string Label to display in place of the data
Example General: Official Corporate Logo
..... creation Σ 0..1 dateTime Date attachment was first created
..... height 0..1 positiveInt Height of the image in pixels (photo/video)
..... width 0..1 positiveInt Width of the image in pixels (photo/video)
..... frames 0..1 positiveInt Number of frames if > 1 (photo)
..... duration 0..1 decimal Length in seconds (audio / video)
..... pages 0..1 positiveInt Number of printed pages
.... profile Σ 0..* BackboneElement Content profile rules for the document
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] Σ 1..1 Code|uri|canonical
Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
...... valueCoding Coding
...... valueUri uri
...... valueCanonical canonical(Any)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.language Base required All Languages 📍5.0.0 FHIR Std.
DocumentReference.status Base required DocumentReferenceStatus 📍5.0.0 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍5.0.0 FHIR Std.
DocumentReference.modality Base extensible Modality . ⏿2025.3.20250714 tx.fhir.org
DocumentReference.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
DocumentReference.category Base example Referenced Item Category Value Set 📍5.0.0 FHIR Std.
DocumentReference.event Base example v3 Code System ActCode 📦3.0.0 THO v7.2
DocumentReference.bodySite Base example SNOMED CT Body Structures 📍5.0.0 FHIR Std.
DocumentReference.facilityType Base example Facility Type Code Value Set 📍5.0.0 FHIR Std.
DocumentReference.practiceSetting Base example Practice Setting Code Value Set 📍5.0.0 FHIR Std.
DocumentReference.attester.​mode Base preferred Composition Attestation Mode 📍5.0.0 FHIR Std.
DocumentReference.relatesTo.​code Base extensible Document Relationship Type 📍5.0.0 FHIR Std.
DocumentReference.securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.contentType Base required Mime Types 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.language Base required All Languages 📍5.0.0 FHIR Std.
DocumentReference.content.​profile.value[x] Base preferred HL7 ValueSet of Format Codes for use with Document Sharing 📦2.1.0 THO v7.2

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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 DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... status ?!SΣ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... type SΣ 1..1 CodeableConcept AI Model Card
Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(EU AI System Device) Reference to the specific AI System Device (Traceability)
... context C 0..* Reference(Appointment | Encounter | EpisodeOfCare) Context of the document content
... description SΣ 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... content SΣ 1..* BackboneElement Document referenced
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment SΣ 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... contentType SΣC 1..1 code Mime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
Example General: text/plain; charset=UTF-8, image/png
..... data SC 0..1 base64Binary Data inline, base64ed
..... url SΣ 0..1 url Uri where the data can be found
Example General: http://www.acme.com/logo-small.png
..... title SΣ 1..1 string Label to display in place of the data
Example General: Official Corporate Logo

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.status Base required DocumentReferenceStatus 📍5.0.0 FHIR Std.
DocumentReference.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.contentType Base required Mime Types 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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 DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from DocumentReference

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference 0..* DocumentReference A reference to a document
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... status S 1..1 code current | superseded | entered-in-error
... type S 1..1 CodeableConcept AI Model Card
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
... description S 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... content S 1..* BackboneElement Document referenced
.... attachment S 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... contentType S 1..1 code Mime type of the content, with charset etc.
..... data S 0..1 base64Binary Data inline, base64ed
..... url S 0..1 url Uri where the data can be found
..... title S 1..1 string Label to display in place of the data

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DocumentReference C 0..* DocumentReference A reference to a document
Constraints: docRef-1, docRef-2
... 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 BindingsPurpose
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
... Slices for extension 4..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:performance S 1..1 (Complex) Metrics & Bias
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-performance-metrics
.... extension:training S 1..1 (Complex) EHDS Permit & Data Quality
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-training-data
.... extension:privacy S 1..1 (Complex) Transfer & Retention
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-privacy-metadata
.... extension:clinicalValidationStatus S 1..1 CodeableConcept AI Clinical Validation Status
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status
Binding: AI Clinical Validation Status ValueSet (required)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifiers for the document
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the DocumentReference
... basedOn 0..* Reference(Appointment | AppointmentResponse | CarePlan | Claim | CommunicationRequest | Contract | CoverageEligibilityRequest | DeviceRequest | EnrollmentRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | RequestOrchestration | ServiceRequest | SupplyRequest | VisionPrescription) Procedure that caused this media to be created
... status ?!SΣ 1..1 code current | superseded | entered-in-error
Binding: DocumentReferenceStatus (required): The status of the document reference.
... docStatus Σ 0..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): Status of the underlying document.
... modality Σ 0..* CodeableConcept Imaging modality used
Binding: Modality . (extensible): Type of acquired data in the instance.
... type SΣ 1..1 CodeableConcept AI Model Card
Binding: FHIRDocumentTypeCodes (preferred): Precise type of clinical document.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: model-card
..... display 1..1 string Representation defined by the system
Fixed Value: AI Model Card
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of document
Binding: ReferencedItemCategoryValueSet (example): High-level kind of document at a macro level.
... subject SΣ 1..1 Reference(EU AI System Device) Reference to the specific AI System Device (Traceability)
... context C 0..* Reference(Appointment | Encounter | EpisodeOfCare) Context of the document content
... event 0..* CodeableReference() Main clinical acts documented
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... bodySite Σ 0..* CodeableReference(BodyStructure) Body part included
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
... facilityType C 0..1 CodeableConcept Kind of facility where patient was seen
Binding: FacilityTypeCodeValueSet (example): XDS Facility Type.
... practiceSetting C 0..1 CodeableConcept Additional details about where the content was created (e.g. clinical specialty)
Binding: PracticeSettingCodeValueSet (example): Additional details about where the content was created (e.g. clinical specialty).
... period Σ 0..1 Period Time of service that is being documented
... date Σ 0..1 instant When this document reference was created
... author Σ 0..* Reference(Practitioner | PractitionerRole | Organization | Device | Patient | RelatedPerson | CareTeam) Who and/or what authored the document
... attester 0..* BackboneElement Attests to accuracy of the document
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a document.
.... time 0..1 dateTime When the document was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the document
... custodian 0..1 Reference(Organization) Organization which maintains the document
... relatesTo Σ 0..* BackboneElement Relationships to other documents
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept The relationship type with another document
Binding: DocumentRelationshipType (extensible): The type of relationship between the documents.
.... target Σ 1..1 Reference(DocumentReference) Target of the relationship
... description SΣ 1..1 markdown Mandatory high-level clinical summary and limitations of the AI model.
... securityLabel Σ 0..* CodeableConcept Document security-tags
Binding: SecurityLabelExamples (example): Example Security Labels from the Healthcare Privacy and Security Classification System.
... content SΣ 1..* BackboneElement Document referenced
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... attachment SΣ 1..1 Attachment Detailed technical documentation and risk assessments (PDF, HTML, etc.)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... contentType SΣC 1..1 code Mime type of the content, with charset etc.
Binding: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
Example General: text/plain; charset=UTF-8, image/png
..... language Σ 0..1 code Human language of the content (BCP-47)
Binding: AllLanguages (required): IETF language tag for a human language.
Additional BindingsPurpose
CommonLanguages Starter

Example General: en-AU
..... data SC 0..1 base64Binary Data inline, base64ed
..... url SΣ 0..1 url Uri where the data can be found
Example General: http://www.acme.com/logo-small.png
..... size Σ 0..1 integer64 Number of bytes of content (if url provided)
..... hash Σ 0..1 base64Binary Hash of the data (sha-1, base64ed)
..... title SΣ 1..1 string Label to display in place of the data
Example General: Official Corporate Logo
..... creation Σ 0..1 dateTime Date attachment was first created
..... height 0..1 positiveInt Height of the image in pixels (photo/video)
..... width 0..1 positiveInt Width of the image in pixels (photo/video)
..... frames 0..1 positiveInt Number of frames if > 1 (photo)
..... duration 0..1 decimal Length in seconds (audio / video)
..... pages 0..1 positiveInt Number of printed pages
.... profile Σ 0..* BackboneElement Content profile rules for the document
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value[x] Σ 1..1 Code|uri|canonical
Binding: HL7 ValueSet of Format Codes for use with Document Sharing (preferred): Document Format Codes.
...... valueCoding Coding
...... valueUri uri
...... valueCanonical canonical(Any)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DocumentReference.language Base required All Languages 📍5.0.0 FHIR Std.
DocumentReference.status Base required DocumentReferenceStatus 📍5.0.0 FHIR Std.
DocumentReference.docStatus Base required Composition Status 📍5.0.0 FHIR Std.
DocumentReference.modality Base extensible Modality . ⏿2025.3.20250714 tx.fhir.org
DocumentReference.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
DocumentReference.category Base example Referenced Item Category Value Set 📍5.0.0 FHIR Std.
DocumentReference.event Base example v3 Code System ActCode 📦3.0.0 THO v7.2
DocumentReference.bodySite Base example SNOMED CT Body Structures 📍5.0.0 FHIR Std.
DocumentReference.facilityType Base example Facility Type Code Value Set 📍5.0.0 FHIR Std.
DocumentReference.practiceSetting Base example Practice Setting Code Value Set 📍5.0.0 FHIR Std.
DocumentReference.attester.​mode Base preferred Composition Attestation Mode 📍5.0.0 FHIR Std.
DocumentReference.relatesTo.​code Base extensible Document Relationship Type 📍5.0.0 FHIR Std.
DocumentReference.securityLabel Base example Example set of Security Labels 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.contentType Base required Mime Types 📍5.0.0 FHIR Std.
DocumentReference.content.​attachment.language Base required All Languages 📍5.0.0 FHIR Std.
DocumentReference.content.​profile.value[x] Base preferred HL7 ValueSet of Format Codes for use with Document Sharing 📦2.1.0 THO v7.2

Constraints

Id Grade Path(s) Description Expression
dom-2 error DocumentReference If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error DocumentReference 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 DocumentReference 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 DocumentReference If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice DocumentReference A resource should have narrative for robust management text.`div`.exists()
docRef-1 warning DocumentReference facilityType SHALL only be present if context is not an encounter facilityType.empty() or context.where(resolve() is Encounter).empty()
docRef-2 warning DocumentReference practiceSetting SHALL only be present if context is not present practiceSetting.empty() or context.where(resolve() is Encounter).empty()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron