{ "resourceType" : "Device", "id" : "device-riskassist-ai", "meta" : { "profile" : ["http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-device"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: Device device-riskassist-ai

Profile: EU AI System Device

Third-Country Data Transfer

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