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
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - 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 <http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-device> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Device device-riskassist-ai</b></p><a name=\"device-riskassist-ai\"> </a><a name=\"hcdevice-riskassist-ai\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-eu-ai-device.html\">EU AI System Device</a></p></div><blockquote><p><b>Third-Country Data Transfer</b></p><ul><li>transferFlag: false</li></ul></blockquote><p><b>Model Card Reference</b>: <a href=\"DocumentReference-modelcard-riskassist-ai.html\">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.</a></p><p><b>identifier</b>: EU AI Database Identifier/EU-AI-000123</p><p><b>status</b>: Active</p><p><b>manufacturer</b>: ExampleMed AI GmbH</p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td><td><b>Type</b></td><td><b>Display</b></td></tr><tr><td style=\"display: none\">*</td><td>RiskAssist AI</td><td>Registered name</td><td>true</td></tr></table><h3>Versions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td>1.0.0</td></tr></table><h3>ConformsTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Category</b></td><td><b>Specification</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">quality-management-system</span></td><td><span title=\"Codes:\">Synthetic QMS certification reference for PoC purposes.</span></td></tr></table><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem ce-mark}\">CE Mark</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem notified-body-id}\">Notified Body ID</span></p><p><b>value</b>: NB-0000</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem expected-lifetime}\">Expected Lifetime</span></p><p><b>value</b>: 5 years<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codea = 'a')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem medical-purpose}\">Medical Purpose</span></p><p><b>value</b>: Supportive risk stratification in acute care settings</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:{http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem target-population}\">Target Population</span></p><p><b>value</b>: <span title=\"Codes:\">Adult patients with suspected infection in an acute care setting</span></p></blockquote><p><b>owner</b>: <a href=\"Organization-organization-examplehospital.html\">Organization Example Hospital</a></p><p><b>contact</b>: <a href=\"mailto:contact@examplemed.example\">contact@examplemed.example</a>, <a href=\"mailto:dpo@examplemed.example\">dpo@examplemed.example</a></p><p><b>note</b>: , </p><blockquote><div><p>Synthetic maintenance information for PoC purposes.</p>\n</div></blockquote><blockquote><div><p>AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.</p>\n</div></blockquote></div>"^^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: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: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." ]
] ) . #
IG © 2026+ Selina Adlberger. Package fhir.ig.eu.aitransparency#0.1.0 based on FHIR 5.0.0. Generated 2026-06-18
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QA Report