0.1.0 - ci-build

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

Resource Profile: Trust AI Provenance

Official URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/trust-ai-provenance Version: 0.1.0
Draft as of 2026-10-02 Computable Name: Trust_AIProvenance

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

Regulatory Requirements

This profile is part of the AI Output Context layer. It implements the following documentation requirements from the Requirements Traceability analysis.

Requirement Law / Source Metadata Field Static / Dynamic
SYS-10 AI Act Art. 12 / EHDS ANNEX II (3) Audit Trail & Access Logging Dynamic
USE-04 GDPR Art. 5(1) Case-Specific Indication Dynamic
LAW-01a GDPR Art. 6(1) Legal Basis (General) Dynamic
LAW-01b GDPR Art. 9(2) Health Data Exception Dynamic
LAW-02 GDPR Art. 22 Automated Decision Flag Dynamic
LAW-03 EHDS Art. 51 / 52 Data Provenance (Primary/Secondary) Dynamic

Element Mapping

Attribute Logical Attribute Card. (matrix) Element(s) in this profile Status Notes
SYS-10.1 Execution Period (Start/End) 1..1 Provenance.occurredPeriod ✅ Covered Also: Trust_AIAuditEvent, Trust_AIObservation.
SYS-10.2 Input Data Reference 1..* Provenance.entity ✅ Covered entity.role = source.
USE-04 Case-Specific Indication 1..* Provenance.extension:caseIndication ✅ Covered Extension case-specific-indication.
LAW-01a Legal Basis Code 1..1 Provenance.authorization:gdprArt6Basis ✅ Covered GDPRArt6LegalBasisVS.
LAW-01b Special Category Exception Code 1..1 Provenance.authorization:gdprArt9Condition ✅ Covered GDPRArt9ConditionVS.
LAW-02 Automated Decision Flag 1..1 Provenance.extension:automatedDecision ✅ Covered Extension automated-decision-flag.
LAW-03.1 Provenance Category 1..1 Provenance.extension:usageCategory ✅ Covered UsageCategoryVS.
LAW-03.2 Data Permit Reference 0..1 Provenance.extension:dataPermit ✅ Covered Complemented by secondaryUsePurpose.

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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... target SΣ 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... start SΣC 1..1 dateTime Start of the AI processing activity
.... end SΣC 1..1 dateTime End of the AI processing activity
... recorded SΣ 1..1 instant Time when the provenance record was created
... 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:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... coding Σ 1..* Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art6-codesystem
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... coding Σ 1..* Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art9-codesystem
... 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(Trust AI System Device) AI system that performed the processing activity
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement Input data used to generate the AI output
.... 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(Resource) Source data processed by the AI system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.4
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... target S 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... start S 1..1 dateTime Start of the AI processing activity
.... end S 1..1 dateTime End of the AI processing activity
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
.... authorization:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding 1..* Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art6-codesystem
..... reference 0..0 Reference to a resource (by instance)
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding 1..* Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art9-codesystem
..... reference 0..0 Reference to a resource (by instance)
... agent S 1..* BackboneElement Actor involved
.... who 1..1 Reference(Trust AI System Device) AI system that performed the processing activity
... entity S 1..* BackboneElement Input data used to generate the AI output
.... role 1..1 code revision | quotation | source | instantiates | removal
Required Pattern: source
.... what 1..1 Reference(Resource) Source data processed by the AI system

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... target SΣ 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Start of the AI processing activity
.... end SΣC 1..1 dateTime End of the AI processing activity
... recorded SΣ 1..1 instant Time when the provenance record was created
... 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:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (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 1..* 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/trust-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
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (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 1..* 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/trust-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
... 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(Trust AI System Device) AI system that performed the processing activity
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement Input data used to generate the AI output
.... 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(Resource) Source data processed by the AI system
.... 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 v7.4
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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()

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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... target SΣ 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... start SΣC 1..1 dateTime Start of the AI processing activity
.... end SΣC 1..1 dateTime End of the AI processing activity
... recorded SΣ 1..1 instant Time when the provenance record was created
... 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:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... coding Σ 1..* Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art6-codesystem
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (required)
..... concept Σ 1..1 CodeableConcept Reference to a concept (by class)
...... coding Σ 1..* Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art9-codesystem
... 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(Trust AI System Device) AI system that performed the processing activity
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement Input data used to generate the AI output
.... 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(Resource) Source data processed by the AI system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Provenance.authorization Base example PurposeOfUse 📦3.1.0 THO v7.4
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... target S 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... start S 1..1 dateTime Start of the AI processing activity
.... end S 1..1 dateTime End of the AI processing activity
... Slices for authorization S 2..* CodeableReference() Authorization (purposeOfUse) related to the event
Slice: Unordered, Open by value:concept.coding.system
.... authorization:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding 1..* Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art6-codesystem
..... reference 0..0 Reference to a resource (by instance)
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (required)
..... concept 1..1 CodeableConcept Reference to a concept (by class)
...... coding 1..* Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://example.org/fhir/trust-ai-transparency/CodeSystem/gdpr-art9-codesystem
..... reference 0..0 Reference to a resource (by instance)
... agent S 1..* BackboneElement Actor involved
.... who 1..1 Reference(Trust AI System Device) AI system that performed the processing activity
... entity S 1..* BackboneElement Input data used to generate the AI output
.... role 1..1 code revision | quotation | source | instantiates | removal
Required Pattern: source
.... what 1..1 Reference(Resource) Source data processed by the AI system

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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 3..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:usageCategory S 1..1 CodeableConcept Primary or secondary use category
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/usage-category
Binding: Usage Category Value Set (required)
.... extension:secondaryUsePurpose S 0..* CodeableConcept Purpose of secondary use, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/secondary-use-purpose
Binding: Secondary-Use Purpose Value Set (required)
.... extension:dataPermit S 0..1 Identifier EHDS data permit, where applicable
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/data-permit
.... extension:caseIndication S 1..1 CodeableConcept Clinical reason for AI use
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/case-specific-indication
Binding: Trust AI Case-Specific Indication Value Set (extensible)
.... extension:automatedDecision S 1..1 boolean Automated decision flag
URL: http://example.org/fhir/trust-ai-transparency/StructureDefinition/automated-decision-flag
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... target SΣ 1..* Reference(Resource) Link to the generated AI clinical result
... occurred[x] S 1..1 Period Period of the activity that generated or influenced the target resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Start of the AI processing activity
.... end SΣC 1..1 dateTime End of the AI processing activity
... recorded SΣ 1..1 instant Time when the provenance record was created
... 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:gdprArt6Basis S 1..1 CodeableReference() Legal basis under GDPR Article 6
Binding: GDPR Article 6 Legal Basis Value Set (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 1..* 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/trust-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
.... authorization:gdprArt9Condition S 1..1 CodeableReference() Condition under GDPR Article 9 for processing health data
Binding: GDPR Article 9 Condition Value Set (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 1..* 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/trust-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
... 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(Trust AI System Device) AI system that performed the processing activity
.... onBehalfOf C 0..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient) The agent that delegated
... entity SΣ 1..* BackboneElement Input data used to generate the AI output
.... 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(Resource) Source data processed by the AI system
.... 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 v7.4
Provenance.authorization:gdprArt6Basis Base required GDPR Article 6 Legal Basis Value Set 📦0.1.0 This IG
Provenance.authorization:gdprArt9Condition Base required GDPR Article 9 Condition Value Set 📦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()

 

Other representations of profile: CSV, Excel, Schematron