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

Extensions

Extensions

The IG defines custom extensions where the FHIR core specification does not sufficiently represent AI transparency, legal context, or regulatory metadata. The Requirement column links to the logical attribute on the Requirements Traceability page that the extension implements.

Static System Context

Extension	Used in	Value	Requirement
Model Card Reference	Trust_AIDevice	Reference to the Trust_AIModelCard	–
EU Conformity Declaration Reference	Trust_AIDevice	Reference to the EU Declaration of Conformity (DocumentReference)	SYS-03a
Third-Country Data Transfer	Trust_AIDevice	transferFlag (boolean), destinationCountry (ISO 3166 code)	LAW-04.1, LAW-04.2
Trust AI DPIA Reference	Trust_AIOrganization	Reference to the DPIA document (DocumentReference)	SYS-09
AI Performance Metrics	Trust_AIModelCard	metric (type, value), biasDisclosure	QUAL-01.1, QUAL-01.2, QUAL-04
AI Training Data Metadata	Trust_AIModelCard	provenance, Category, SecondaryUsePurpose, Permit, dataQuality	QUAL-02a, QUAL-02b, QUAL-02c, QUAL-03
AI Retention Information	Trust_AIModelCard	retention (Duration)	LAW-06
AI Clinical Validation Status	Trust_AIModelCard	CodeableConcept	–

AI Output Context

Extension	Used in	Value	Requirement
Usage Category	Trust_AIProvenance	CodeableConcept (primary or secondary use)	LAW-03.1
Secondary Use Purpose	Trust_AIProvenance	CodeableConcept	LAW-03.2
Data Permit	Trust_AIProvenance	Identifier	LAW-03.2
Case-Specific Indication	Trust_AIProvenance	CodeableConcept	USE-04
Automated Decision-Making Flag	Trust_AIProvenance	boolean	LAW-02
Trust AI Log Integrity Signature	Trust_AIAuditEvent	Signature	LAW-08

Clinical Decision Context

Extension	Used in	Value	Requirement
AI System-Specific Training Status	Trust_AIPractitionerRole	boolean	HL-02.2
Patient AI Info Provided Flag	Trust_AIPatientExplanation	boolean	LAW-01c