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 Human Oversight Assessment

Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-human-oversight Version: 0.1.0
Draft as of 2026-07-31 Computable Name: EU_AIHumanOversightAssessment

An ArtifactAssessment profile documenting professional review of an AI-generated output, including whether the result was accepted, corrected, modified, or overridden.

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
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for artifact[x] Σ 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Closed by type:$this
.... artifact[x]:artifactReference SΣ 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content 0..* BackboneElement Comment, classifier, or rating content
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ArtifactAssessment If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ArtifactAssessment 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 ArtifactAssessment 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 ArtifactAssessment If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ArtifactAssessment 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()

This structure is derived from ArtifactAssessment

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... date S 1..1 dateTime Date and time of human oversight assessment
... Slices for artifact[x] 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Open by type:$this
.... artifact[x]:artifactReference S 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Additional identifier for the artifact assessment
... title Σ 0..1 string A short title for the assessment for use in displaying and selecting
... citeAs[x] 0..1 How to cite the comment or rating
.... citeAsReference Reference(Citation)
.... citeAsMarkdown markdown
... date SΣ 1..1 dateTime Date and time of human oversight assessment
... copyright 0..1 markdown Use and/or publishing restrictions
... approvalDate 0..1 date When the artifact assessment was approved by publisher
... lastReviewDate Σ 0..1 date When the artifact assessment was last reviewed by the publisher
... Slices for artifact[x] Σ 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Closed by type:$this
.... artifact[x]:artifactReference SΣ 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content 0..* BackboneElement Comment, classifier, or rating content
.... 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
.... informationType 0..1 code comment | classifier | rating | container | response | change-request
Binding: ArtifactAssessmentInformationType (required)
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... type 0..1 CodeableConcept What type of content
Binding: EvidenceCertaintyType (example)
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... quantity 0..1 Quantity Quantitative rating
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... path 0..* uri What the comment is directed to
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence
.... freeToShare 0..1 boolean Acceptable to publicly share the resource content
.... component 0..* See content (ArtifactAssessment) Contained content
... workflowStatus Σ 0..1 code submitted | triaged | waiting-for-input | resolved-no-change | resolved-change-required | deferred | duplicate | applied | published | entered-in-error
Binding: ArtifactAssessmentWorkflowStatus (required)
... disposition Σ 0..1 code unresolved | not-persuasive | persuasive | persuasive-with-modification | not-persuasive-with-modification
Binding: ArtifactAssessmentDisposition (required)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ArtifactAssessment.language Base required All Languages 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​informationType Base required Artifact Assessment Information Type 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​type Base example Evidence Certainty Type 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG
ArtifactAssessment.workflowStatus Base required Artifact Assessment Workflow Status 📍5.0.0 FHIR Std.
ArtifactAssessment.disposition Base required Artifact Assessment Disposition 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ArtifactAssessment If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ArtifactAssessment 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 ArtifactAssessment 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 ArtifactAssessment If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ArtifactAssessment 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()

This structure is derived from ArtifactAssessment

Summary

Mandatory: 2 elements(2 nested mandatory elements)
Must-Support: 5 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ArtifactAssessment.artifact[x]

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for artifact[x] Σ 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Closed by type:$this
.... artifact[x]:artifactReference SΣ 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content 0..* BackboneElement Comment, classifier, or rating content
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error ArtifactAssessment If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ArtifactAssessment 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 ArtifactAssessment 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 ArtifactAssessment If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ArtifactAssessment 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()

Differential View

This structure is derived from ArtifactAssessment

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... date S 1..1 dateTime Date and time of human oversight assessment
... Slices for artifact[x] 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Open by type:$this
.... artifact[x]:artifactReference S 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ArtifactAssessment 0..* ArtifactAssessment Adds metadata-supported comments, classifiers or ratings related to a Resource
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Additional identifier for the artifact assessment
... title Σ 0..1 string A short title for the assessment for use in displaying and selecting
... citeAs[x] 0..1 How to cite the comment or rating
.... citeAsReference Reference(Citation)
.... citeAsMarkdown markdown
... date SΣ 1..1 dateTime Date and time of human oversight assessment
... copyright 0..1 markdown Use and/or publishing restrictions
... approvalDate 0..1 date When the artifact assessment was approved by publisher
... lastReviewDate Σ 0..1 date When the artifact assessment was last reviewed by the publisher
... Slices for artifact[x] Σ 1..1 Reference(Resource) Reference to the AI-generated Observation
Slice: Unordered, Closed by type:$this
.... artifact[x]:artifactReference SΣ 1..1 Reference(EU AI Generated Observation) The artifact assessed, commented upon or rated
... content 0..* BackboneElement Comment, classifier, or rating content
.... 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
.... informationType 0..1 code comment | classifier | rating | container | response | change-request
Binding: ArtifactAssessmentInformationType (required)
.... summary S 0..1 markdown Clinical or technical rationale for the assessment
.... type 0..1 CodeableConcept What type of content
Binding: EvidenceCertaintyType (example)
.... classifier S 1..1 CodeableConcept Human oversight action
Binding: EU AI Human Oversight Action Value Set (extensible)
.... quantity 0..1 Quantity Quantitative rating
.... author S 1..1 Reference(EU AI Practitioner Role) Reference to the qualified human overseer
.... path 0..* uri What the comment is directed to
.... relatedArtifact 0..* RelatedArtifact Supporting documentation or explainability evidence
.... freeToShare 0..1 boolean Acceptable to publicly share the resource content
.... component 0..* See content (ArtifactAssessment) Contained content
... workflowStatus Σ 0..1 code submitted | triaged | waiting-for-input | resolved-no-change | resolved-change-required | deferred | duplicate | applied | published | entered-in-error
Binding: ArtifactAssessmentWorkflowStatus (required)
... disposition Σ 0..1 code unresolved | not-persuasive | persuasive | persuasive-with-modification | not-persuasive-with-modification
Binding: ArtifactAssessmentDisposition (required)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ArtifactAssessment.language Base required All Languages 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​informationType Base required Artifact Assessment Information Type 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​type Base example Evidence Certainty Type 📍5.0.0 FHIR Std.
ArtifactAssessment.content.​classifier Base extensible EU AI Human Oversight Action Value Set 📦0.1.0 This IG
ArtifactAssessment.workflowStatus Base required Artifact Assessment Workflow Status 📍5.0.0 FHIR Std.
ArtifactAssessment.disposition Base required Artifact Assessment Disposition 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ArtifactAssessment If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ArtifactAssessment 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 ArtifactAssessment 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 ArtifactAssessment If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ArtifactAssessment 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()

This structure is derived from ArtifactAssessment

Summary

Mandatory: 2 elements(2 nested mandatory elements)
Must-Support: 5 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ArtifactAssessment.artifact[x]

 

Other representations of profile: CSV, Excel, Schematron