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

Example Device: Device: RiskAssist AI

Third-Country Data Transfer

  • transferFlag: false

Model Card Reference: DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.

identifier: EU AI Database Identifier/EU-AI-000123

status: Active

manufacturer: ExampleMed AI GmbH

Names

-ValueTypeDisplay
*RiskAssist AIRegistered nametrue

Versions

-Value
*1.0.0

ConformsTos

-CategorySpecification
*quality-management-systemSynthetic QMS certification reference for PoC purposes.

property

type: CE Mark

value: true

property

type: Notified Body ID

value: NB-0000

property

type: Expected Lifetime

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

property

type: Medical Purpose

value: Supportive risk stratification in acute care settings

property

type: Target Population

value: Adult patients with suspected infection in an acute care setting

owner: Organization Example Hospital

contact: contact@examplemed.example, dpo@examplemed.example

note: ,

Synthetic maintenance information for PoC purposes.

AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.