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