0.1.0 - ci-build

TrustAITransparencyIG, published by Selina Adlberger. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7Austria/AIST-TrustworthyAI-R5/ and changes regularly. See the Directory of published versions

Example Device: Device: DiagnosticAssist AI

Third-Country Data Transfer

  • transferFlag: false

Model Card Reference: DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; date = 2026-03-01 10:00:00+0000; description = Synthetic model card for an AI system generating diagnostic reports from structured clinical input.

EU Conformity Declaration Reference: DocumentReference: status = current

identifier: Trust AI Registration Number/trust-ai-DIAG-001

status: Active

manufacturer: Example AI Medical GmbH

Names

-ValueType
*DiagnosticAssist AIRegistered name

Versions

-Value
*1.0.0

ConformsTos

-Specification
*Synthetic quality management certification

property

type: CE Marking Status

value: true

property

type: Expected Lifetime

value: 5 years (Details: UCUM codea = 'a')

property

type: Intended Purpose

value: Support diagnostic assessment from clinical findings

property

type: Target Population

value: Adult patients

owner: Organization Example Diagnostic Center

contact: manufacturer@example-ai-medical.example, dpo@example-ai-medical.example

note:

Annual maintenance and validation required.