@prefix fhir: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:Device ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "device-riskassist-ai"] ; # fhir:meta [ fhir:profile ( [ fhir:v "http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-device"^^xsd:anyURI ; fhir:link ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "

Generated Narrative: 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.

\n

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

\n
"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:extension ( [ fhir:url [ fhir:v "transferFlag"^^xsd:anyURI ] ; fhir:value [ a fhir:boolean ; fhir:v false ] ] ) ; fhir:url [ fhir:v "http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:link ; fhir:reference [ fhir:v "DocumentReference/modelcard-riskassist-ai" ] ] ] ) ; # fhir:identifier ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "eu-ai-database-id" ] ; fhir:display [ fhir:v "EU AI Database Identifier" ] ] ) ; fhir:text [ fhir:v "EU AI Database Identifier" ] ] ; fhir:system [ fhir:v "http://example.org/fhir/sid/eu-ai-database"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU-AI-000123" ] ] ) ; # fhir:status [ fhir:v "active"] ; # fhir:manufacturer [ fhir:v "ExampleMed AI GmbH"] ; # fhir:name ( [ fhir:value [ fhir:v "RiskAssist AI" ] ; fhir:type [ fhir:v "registered-name" ] ; fhir:display [ fhir:v true ] ] ) ; # fhir:version ( [ fhir:value [ fhir:v "1.0.0" ] ] ) ; # fhir:conformsTo ( [ fhir:category [ fhir:text [ fhir:v "quality-management-system" ] ] ; fhir:specification [ fhir:text [ fhir:v "Synthetic QMS certification reference for PoC purposes." ] ] ] ) ; # fhir:property ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "ce-mark" ] ] ) ] ; fhir:value [ a fhir:boolean ; fhir:v true ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "notified-body-id" ] ] ) ] ; fhir:value [ a fhir:string ; fhir:v "NB-0000" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "expected-lifetime" ] ] ) ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "5"^^xsd:decimal ] ; fhir:unit [ fhir:v "years" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "a" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "medical-purpose" ] ] ) ] ; fhir:value [ a fhir:string ; fhir:v "Supportive risk stratification in acute care settings" ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI ] ; fhir:code [ fhir:v "target-population" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Adult patients with suspected infection in an acute care setting" ] ] ] ) ; # fhir:owner [ fhir:link ; fhir:reference [ fhir:v "Organization/organization-examplehospital" ] ] ; # fhir:contact ( [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "contact@examplemed.example" ] ; fhir:use [ fhir:v "work" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "dpo@examplemed.example" ] ; fhir:use [ fhir:v "work" ] ] ) ; # fhir:note ( [ fhir:text [ fhir:v "Synthetic maintenance information for PoC purposes." ] ] [ fhir:text [ fhir:v "AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters." ] ] ) . # # -------------------------------------------------------------------------------------