EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Extension: AI Clinical Validation Status
| Official URL: http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status | Version: 0.1.0 | |||
| Draft as of 2026-06-18 | Computable Name: AIClinicalValidationStatus | |||
Documents whether the AI system is clinically validated, not clinically validated, under validation, or only technically validated.
Context of Use
-
Element ID:
DocumentReference
This extension may be used on the following element(s)
Usage info
Usages:
- Use this Extension: EU AI Act Model Card
- Examples for this Extension: DocumentReference/modelcard-riskassist-ai
You can also check for usages in the FHIR IG Statistics
Formal Views of Extension Content
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Extension |
0..* | Extension | AI Clinical Validation Status | |
  extension |
0..0 | Extension | ||
| url |
1..1 | uri | "http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status" | |
  value[x] |
0..1 | CodeableConcept | Value of extension Binding: AI Clinical Validation Status ValueSet (required) | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | AI Clinical Validation Status | |
 id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status" | |
| value[x] |
0..1 | CodeableConcept | Value of extension Binding: AI Clinical Validation Status ValueSet (required) | |
| Documentation for this format | ||||
This structure is derived from Extension
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | AI Clinical Validation Status | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status" | |
| value[x] |
0..1 | CodeableConcept | Value of extension Binding: AI Clinical Validation Status ValueSet (required) | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | AI Clinical Validation Status | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "http://example.org/fhir/eu-ai-transparency/StructureDefinition/ai-clinical-validation-status" | |
| value[x] |
0..1 | CodeableConcept | Value of extension Binding: AI Clinical Validation Status ValueSet (required) | |
| Documentation for this format | ||||
This structure is derived from Extension
Other representations of profile: CSV, Excel, Schematron
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Extension.value[x] | Base | required | AI Clinical Validation Status ValueSet | 📦0.1.0 | This IG |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| 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()
|