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

Terminology

Terminology

The Implementation Guide defines custom terminology where existing FHIR terminologies do not sufficiently represent AI transparency concepts. It contains 16 CodeSystems and 12 ValueSets.

AI Transparency and Documentation

Code System Codes Value Set (Binding) Used in
Trust AI Involvement ai-generated, ai-assisted, ai-reported, ai-asserted Trust AI Involvement (required) TrustAIData meta.security, Trust_AIObservation interpretation
Trust AI Performance Metric accuracy, sensitivity, specificity, robustness Trust AI Performance Metric (extensible) AI Performance Metrics
Trust AI Clinical Validation Status clinically-validated, not-clinically-validated, validation-in-progress, technical-validation-only Trust AI Clinical Validation Status (required) AI Clinical Validation Status
Trust AI Data Quality representative, error-free, complete, relevant Trust AI Data Quality (extensible) AI Training Data Metadata
Trust AI Case-Specific Indication triage, screening, second-opinion, diagnostic-support, treatment-planning, prognosis Trust AI Case-Specific Indication (extensible) Case-Specific Indication

Human Oversight

Code System Codes Value Set (Binding) Used in
Trust AI Human Oversight human-validation, human-override, human-correction Trust AI Human Oversight Action (extensible) Trust_AIHumanOversightAssessment content.classifier

GDPR

Code System Codes Value Set (Binding) Used in
GDPR Article 6 Legal Basis Art. 6(1)(a) to (f) GDPR Article 6 Legal Basis (required) Trust_AIProvenance authorization
GDPR Article 9 Condition Art. 9(2)(a), (c), (g), (h), (i), (j) GDPR Article 9 Condition (required) Trust_AIProvenance authorization

European Health Data Space (EHDS)

Code System Codes Value Set (Binding) Used in
Usage Category primary-use, secondary-use Usage Category (required) Usage Category
Data Category 17 categories of electronic health data for secondary use Data Category (extensible) AI Training Data Metadata
Secondary-Use Purpose 8 permitted purposes of secondary use Secondary-Use Purpose (required in Secondary Use Purpose, extensible in AI Training Data Metadata) Secondary Use Purpose, AI Training Data Metadata

Structural Codes

These code systems provide fixed codes that identify slices and document types within the profiles.

Code System Codes Value Set (Binding) Used in
Trust AI Contact Purpose dpo, ai-incident-reporting – Trust_AIOrganization contact.purpose
Trust AI Artifact Type model-card – Trust_AIModelCard type
Trust AI Identifier Type trust-ai-registration-number – Trust_AIDevice identifier.type
Trust AI System Property ce-mark, notified-body-id, expected-lifetime, intended-purpose, target-population – Trust_AIDevice property.type
Trust AI Audit Entity Role reference-database, ai-output Trust AI Audit Entity Role Trust_AIAuditEvent entity.role