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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 Provenance

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

A Provenance profile linking an AI-generated output to the contributing AI system, source data, and relevant processing or governance context.

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
.. Provenance 0..* Provenance Who, What, When for a set of resources
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... target SΣ 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
... agent SΣC 1..* BackboneElement Actor involved
Constraints: prov-1, prov-2, prov-3
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... who ΣC 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement An entity used in this activity
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 1..1 code revision | quotation | source | instantiates | removal
Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
Required Pattern: source
.... what Σ 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG
Provenance.entity.role Base required Provenance Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Provenance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Provenance 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 Provenance 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 Provenance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Provenance A resource should have narrative for robust management text.`div`.exists()
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()
prov-1 error Provenance.agent Who and onBehalfOf cannot be the same who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2 error Provenance.agent If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3 error Provenance.agent If who is an organization, onBehalfOf can't be a PractitionerRole within that organization who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Provenance 0..* Provenance Who, What, When for a set of resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... target S 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
... agent S 1..* BackboneElement Actor involved
.... who 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
... entity S 1..* BackboneElement An entity used in this activity
.... role 1..1 code revision | quotation | source | instantiates | removal
Required Pattern: source
.... what 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Provenance 0..* Provenance Who, What, When for a set of resources
... 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
... 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 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... target SΣ 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
... recorded Σ 0..1 instant When the activity was recorded / updated
... policy 0..* uri Policy or plan the activity was defined by
... location 0..1 Reference(Location) Where the activity occurred, if relevant
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
... activity 0..1 CodeableConcept Activity that occurred
Binding: ProvenanceActivityType (example): The activity that took place.
... basedOn 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task) Workflow authorization within which this event occurred
... patient 0..1 Reference(Patient) The patient is the subject of the data created/updated (.target) by the activity
... encounter 0..1 Reference(Encounter) Encounter within which this event occurred or which the event is tightly associated
... agent SΣC 1..* BackboneElement Actor involved
Constraints: prov-1, prov-2, prov-3
.... 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
.... type Σ 0..1 CodeableConcept How the agent participated
Binding: ParticipationRoleType (example): The type of participation that a provenance agent played with respect to the activity.
.... role 0..* CodeableConcept What the agents role was
Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity.
.... who ΣC 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement An entity used in this activity
.... 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
.... role Σ 1..1 code revision | quotation | source | instantiates | removal
Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
Required Pattern: source
.... what Σ 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI
.... agent 0..* See agent (Provenance) Entity is attributed to this agent
... signature 0..* Signature Signature on target

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.language Base required All Languages 📍5.0.0 FHIR Std.
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG
Provenance.activity Base example ValueSet of sample of representative activity type codes. 📍5.0.0 FHIR Std.
Provenance.agent.type Base example Participation Role Type 📍5.0.0 FHIR Std.
Provenance.agent.role Base example Security Role Type 📍5.0.0 FHIR Std.
Provenance.entity.role Base required Provenance Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Provenance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Provenance 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 Provenance 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 Provenance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Provenance A resource should have narrative for robust management text.`div`.exists()
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()
prov-1 error Provenance.agent Who and onBehalfOf cannot be the same who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2 error Provenance.agent If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3 error Provenance.agent If who is an organization, onBehalfOf can't be a PractitionerRole within that organization who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

Summary

Mandatory: 8 elements(2 nested mandatory elements)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Provenance.authorization

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Provenance 0..* Provenance Who, What, When for a set of resources
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... target SΣ 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
... agent SΣC 1..* BackboneElement Actor involved
Constraints: prov-1, prov-2, prov-3
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... who ΣC 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement An entity used in this activity
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... role Σ 1..1 code revision | quotation | source | instantiates | removal
Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
Required Pattern: source
.... what Σ 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG
Provenance.entity.role Base required Provenance Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Provenance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Provenance 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 Provenance 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 Provenance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Provenance A resource should have narrative for robust management text.`div`.exists()
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()
prov-1 error Provenance.agent Who and onBehalfOf cannot be the same who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2 error Provenance.agent If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3 error Provenance.agent If who is an organization, onBehalfOf can't be a PractitionerRole within that organization who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

Differential View

This structure is derived from Provenance

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Provenance 0..* Provenance Who, What, When for a set of resources
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... target S 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
... agent S 1..* BackboneElement Actor involved
.... who 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
... entity S 1..* BackboneElement An entity used in this activity
.... role 1..1 code revision | quotation | source | instantiates | removal
Required Pattern: source
.... what 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Provenance 0..* Provenance Who, What, When for a set of resources
... 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
... 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 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary vs. Secondary Use Category
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-usage-category
Binding: EHDS Usage Category ValueSet (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept EHDS Secondary Use Purpose
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-secondary-use-purpose
Binding: EHDS Secondary Use Purpose ValueSet (required)
.... extension:dataPermit S 0..1 Identifier Reference to the EHDS Data Access Permit
URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ehds-data-permit
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... target SΣ 1..* Reference(EU AI Generated Observation) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Exact execution period (Start/End) of the AI model
... recorded Σ 0..1 instant When the activity was recorded / updated
... policy 0..* uri Policy or plan the activity was defined by
... location 0..1 Reference(Location) Where the activity occurred, if relevant
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
.... authorization:gdprBasis S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 6 Legal Basis ValueSet (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art6-codesystem
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... authorization:gdprException S 1..1 CodeableReference() Authorization (purposeOfUse) related to the event
Binding: GDPR Article 9 Exception ValueSet (required)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/eu-ai-transparency/CodeSystem/gdpr-art9-codesystem
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
... activity 0..1 CodeableConcept Activity that occurred
Binding: ProvenanceActivityType (example): The activity that took place.
... basedOn 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task) Workflow authorization within which this event occurred
... patient 0..1 Reference(Patient) The patient is the subject of the data created/updated (.target) by the activity
... encounter 0..1 Reference(Encounter) Encounter within which this event occurred or which the event is tightly associated
... agent SΣC 1..* BackboneElement Actor involved
Constraints: prov-1, prov-2, prov-3
.... 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
.... type Σ 0..1 CodeableConcept How the agent participated
Binding: ParticipationRoleType (example): The type of participation that a provenance agent played with respect to the activity.
.... role 0..* CodeableConcept What the agents role was
Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity.
.... who ΣC 1..1 Reference(EU AI System Device) Link to the AI Device that executed the action
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement An entity used in this activity
.... 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
.... role Σ 1..1 code revision | quotation | source | instantiates | removal
Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
Required Pattern: source
.... what Σ 1..1 Reference(Observation | ImagingStudy | DocumentReference) Source data processed by the AI
.... agent 0..* See agent (Provenance) Entity is attributed to this agent
... signature 0..* Signature Signature on target

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.language Base required All Languages 📍5.0.0 FHIR Std.
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.2
Provenance.authorization:gdprBasis Base required GDPR Article 6 Legal Basis ValueSet 📦0.1.0 This IG
Provenance.authorization:gdprException Base required GDPR Article 9 Exception ValueSet 📦0.1.0 This IG
Provenance.activity Base example ValueSet of sample of representative activity type codes. 📍5.0.0 FHIR Std.
Provenance.agent.type Base example Participation Role Type 📍5.0.0 FHIR Std.
Provenance.agent.role Base example Security Role Type 📍5.0.0 FHIR Std.
Provenance.entity.role Base required Provenance Entity Role 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Provenance If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Provenance 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 Provenance 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 Provenance If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Provenance A resource should have narrative for robust management text.`div`.exists()
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()
prov-1 error Provenance.agent Who and onBehalfOf cannot be the same who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2 error Provenance.agent If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3 error Provenance.agent If who is an organization, onBehalfOf can't be a PractitionerRole within that organization who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

Summary

Mandatory: 8 elements(2 nested mandatory elements)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Provenance.authorization

 

Other representations of profile: CSV, Excel, Schematron