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EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: Device: RiskAssist AI - XML Representation

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<Device xmlns="http://hl7.org/fhir">
  <id value="device-riskassist-ai"/>
  <meta>
    <profile
             value="http://example.org/fhir/eu-ai-transparency/StructureDefinition/eu-ai-device"/>
  </meta>
  <text>
    <status value="extensions"/>
    <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>
</div></blockquote><blockquote><div><p>AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.</p>
</div></blockquote></div>
  </text>
  <extension
             url="http://example.org/fhir/eu-ai-transparency/StructureDefinition/third-country-data-transfer">
    <extension url="transferFlag">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://example.org/fhir/eu-ai-transparency/StructureDefinition/ext-model-card">
    <valueReference>🔗 
      <reference value="DocumentReference/modelcard-riskassist-ai"/>
    </valueReference>
  </extension>
  <identifier>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="eu-ai-database-id"/>
        <display value="EU AI Database Identifier"/>
      </coding>
      <text value="EU AI Database Identifier"/>
    </type>
    <system value="http://example.org/fhir/sid/eu-ai-database"/>
    <value value="EU-AI-000123"/>
  </identifier>
  <status value="active"/>
  <manufacturer value="ExampleMed AI GmbH"/>
  <name>
    <value value="RiskAssist AI"/>
    <type value="registered-name"/>
    <display value="true"/>
  </name>
  <version>
    <value value="1.0.0"/>
  </version>
  <conformsTo>
    <category>
      <text value="quality-management-system"/>
    </category>
    <specification>
      <text value="Synthetic QMS certification reference for PoC purposes."/>
    </specification>
  </conformsTo>
  <property>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="ce-mark"/>
      </coding>
    </type>
    <valueBoolean value="true"/>
  </property>
  <property>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="notified-body-id"/>
      </coding>
    </type>
    <valueString value="NB-0000"/>
  </property>
  <property>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="expected-lifetime"/>
      </coding>
    </type>
    <valueQuantity>
      <value value="5"/>
      <unit value="years"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="a"/>
    </valueQuantity>
  </property>
  <property>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="medical-purpose"/>
      </coding>
    </type>
    <valueString
                 value="Supportive risk stratification in acute care settings"/>
  </property>
  <property>
    <type>
      <coding>
        <system
                value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
        <code value="target-population"/>
      </coding>
    </type>
    <valueCodeableConcept>
      <text
            value="Adult patients with suspected infection in an acute care setting"/>
    </valueCodeableConcept>
  </property>
  <owner>🔗 
    <reference value="Organization/organization-examplehospital"/>
  </owner>
  <contact>
    <system value="email"/>
    <value value="contact@examplemed.example"/>
    <use value="work"/>
  </contact>
  <contact>
    <system value="email"/>
    <value value="dpo@examplemed.example"/>
    <use value="work"/>
  </contact>
  <note>
    <text value="Synthetic maintenance information for PoC purposes."/>
  </note>
  <note>
    <text
          value="AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters."/>
  </note>
</Device>