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
| Active as of 2026-06-18 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="EUAIActCodeSystem"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem EUAIActCodeSystem</b></p><a name="EUAIActCodeSystem"> </a><a name="hcEUAIActCodeSystem"> </a><p>This case-sensitive code system <code>http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">ai-system<a name="EUAIActCodeSystem-ai-system"> </a></td><td>AI System</td><td/></tr><tr><td style="white-space:nowrap">high-risk-ai<a name="EUAIActCodeSystem-high-risk-ai"> </a></td><td>High-Risk AI System</td><td/></tr><tr><td style="white-space:nowrap">gpai<a name="EUAIActCodeSystem-gpai"> </a></td><td>General Purpose AI</td><td/></tr><tr><td style="white-space:nowrap">model-card<a name="EUAIActCodeSystem-model-card"> </a></td><td>AI Model Card</td><td/></tr><tr><td style="white-space:nowrap">ai-generated<a name="EUAIActCodeSystem-ai-generated"> </a></td><td>AI Generated Result</td><td/></tr><tr><td style="white-space:nowrap">human-override<a name="EUAIActCodeSystem-human-override"> </a></td><td>Human Override</td><td/></tr><tr><td style="white-space:nowrap">human-validation<a name="EUAIActCodeSystem-human-validation"> </a></td><td>Human Validation</td><td/></tr><tr><td style="white-space:nowrap">human-correction<a name="EUAIActCodeSystem-human-correction"> </a></td><td>Human Correction</td><td/></tr><tr><td style="white-space:nowrap">ai-transparency-info<a name="EUAIActCodeSystem-ai-transparency-info"> </a></td><td>AI Transparency Information</td><td/></tr><tr><td style="white-space:nowrap">patient-information-provided<a name="EUAIActCodeSystem-patient-information-provided"> </a></td><td>Patient Information Provided</td><td/></tr><tr><td style="white-space:nowrap">patient-explanation-requested<a name="EUAIActCodeSystem-patient-explanation-requested"> </a></td><td>Patient Explanation Requested</td><td/></tr><tr><td style="white-space:nowrap">patient-explanation-provided<a name="EUAIActCodeSystem-patient-explanation-provided"> </a></td><td>Patient Explanation Provided</td><td/></tr><tr><td style="white-space:nowrap">accuracy<a name="EUAIActCodeSystem-accuracy"> </a></td><td>Accuracy</td><td/></tr><tr><td style="white-space:nowrap">sensitivity<a name="EUAIActCodeSystem-sensitivity"> </a></td><td>Sensitivity</td><td/></tr><tr><td style="white-space:nowrap">specificity<a name="EUAIActCodeSystem-specificity"> </a></td><td>Specificity</td><td/></tr><tr><td style="white-space:nowrap">robustness<a name="EUAIActCodeSystem-robustness"> </a></td><td>Robustness</td><td/></tr><tr><td style="white-space:nowrap">clinically-validated<a name="EUAIActCodeSystem-clinically-validated"> </a></td><td>Clinically Validated</td><td>The AI system has completed clinical validation.</td></tr><tr><td style="white-space:nowrap">not-clinically-validated<a name="EUAIActCodeSystem-not-clinically-validated"> </a></td><td>Not Clinically Validated</td><td>The AI system has not completed clinical validation.</td></tr><tr><td style="white-space:nowrap">validation-in-progress<a name="EUAIActCodeSystem-validation-in-progress"> </a></td><td>Validation In Progress</td><td>Clinical validation is currently in progress.</td></tr><tr><td style="white-space:nowrap">technical-validation-only<a name="EUAIActCodeSystem-technical-validation-only"> </a></td><td>Technical Validation Only</td><td>Only technical or syntactic validation has been performed.</td></tr><tr><td style="white-space:nowrap">triage<a name="EUAIActCodeSystem-triage"> </a></td><td>Triage and Prioritization</td><td/></tr><tr><td style="white-space:nowrap">screening<a name="EUAIActCodeSystem-screening"> </a></td><td>Screening</td><td/></tr><tr><td style="white-space:nowrap">second-opinion<a name="EUAIActCodeSystem-second-opinion"> </a></td><td>Second Opinion</td><td/></tr><tr><td style="white-space:nowrap">diagnostic-support<a name="EUAIActCodeSystem-diagnostic-support"> </a></td><td>Diagnostic Support</td><td/></tr><tr><td style="white-space:nowrap">treatment-planning<a name="EUAIActCodeSystem-treatment-planning"> </a></td><td>Treatment Planning</td><td/></tr><tr><td style="white-space:nowrap">prognosis<a name="EUAIActCodeSystem-prognosis"> </a></td><td>Prognostic Prediction</td><td/></tr><tr><td style="white-space:nowrap">ce-mark<a name="EUAIActCodeSystem-ce-mark"> </a></td><td>CE Mark</td><td>Indicates whether the device has a CE mark.</td></tr><tr><td style="white-space:nowrap">notified-body-id<a name="EUAIActCodeSystem-notified-body-id"> </a></td><td>Notified Body ID</td><td>Identifier of the notified body.</td></tr><tr><td style="white-space:nowrap">expected-lifetime<a name="EUAIActCodeSystem-expected-lifetime"> </a></td><td>Expected Lifetime</td><td>The expected lifetime of the AI system.</td></tr><tr><td style="white-space:nowrap">medical-purpose<a name="EUAIActCodeSystem-medical-purpose"> </a></td><td>Medical Purpose</td><td>The intended medical purpose.</td></tr><tr><td style="white-space:nowrap">target-population<a name="EUAIActCodeSystem-target-population"> </a></td><td>Target Population</td><td>The intended target population.</td></tr><tr><td style="white-space:nowrap">eu-ai-database-id<a name="EUAIActCodeSystem-eu-ai-database-id"> </a></td><td>EU AI Database Identifier</td><td>Identifier for an AI system registration in the EU AI database or an equivalent AI system registry.</td></tr><tr><td style="white-space:nowrap">primary-use<a name="EUAIActCodeSystem-primary-use"> </a></td><td>Primary Use</td><td>Processing for direct patient care.</td></tr><tr><td style="white-space:nowrap">secondary-use<a name="EUAIActCodeSystem-secondary-use"> </a></td><td>Secondary Use</td><td>Processing for research, AI training, policy making, or other permitted secondary-use purposes.</td></tr><tr><td style="white-space:nowrap">ehr<a name="EUAIActCodeSystem-ehr"> </a></td><td>Electronic Health Records (EHRs)</td><td>Electronic health data from electronic health records (Art. 51 1a).</td></tr><tr><td style="white-space:nowrap">health-factors<a name="EUAIActCodeSystem-health-factors"> </a></td><td>Health Determinants</td><td>Data impacting health, including socioeconomic, environmental and behavioural determinants (Art. 51 1b).</td></tr><tr><td style="white-space:nowrap">healthcare-resources<a name="EUAIActCodeSystem-healthcare-resources"> </a></td><td>Aggregated Healthcare Data</td><td>Aggregated data on healthcare needs, resources, access and financing (Art. 51 1c).</td></tr><tr><td style="white-space:nowrap">pathogen-data<a name="EUAIActCodeSystem-pathogen-data"> </a></td><td>Pathogen Data</td><td>Data on pathogens impacting human health (Art. 51 1d).</td></tr><tr><td style="white-space:nowrap">admin-claims<a name="EUAIActCodeSystem-admin-claims"> </a></td><td>Administrative and Claims Data</td><td>Health-related administrative data, including claims and reimbursement data (Art. 51 1e).</td></tr><tr><td style="white-space:nowrap">human-genomic<a name="EUAIActCodeSystem-human-genomic"> </a></td><td>Human Genomic Data</td><td>Human genetic, epigenomic and genomic data (Art. 51 1f).</td></tr><tr><td style="white-space:nowrap">molecular-omics<a name="EUAIActCodeSystem-molecular-omics"> </a></td><td>Molecular Omic Data</td><td>Other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data (Art. 51 1g).</td></tr><tr><td style="white-space:nowrap">device-generated-personal<a name="EUAIActCodeSystem-device-generated-personal"> </a></td><td>Device-Generated Personal Data</td><td>Person-generated electronic health data automatically generated by medical devices (Art. 51 1h).</td></tr><tr><td style="white-space:nowrap">wellness-apps<a name="EUAIActCodeSystem-wellness-apps"> </a></td><td>Wellness Application Data</td><td>Data from wellness applications (Art. 51 1i).</td></tr><tr><td style="white-space:nowrap">professional-status<a name="EUAIActCodeSystem-professional-status"> </a></td><td>Healthcare Professional Data</td><td>Data on the professional status, specialization and institution of healthcare professionals (Art. 51 1j).</td></tr><tr><td style="white-space:nowrap">public-health-registry<a name="EUAIActCodeSystem-public-health-registry"> </a></td><td>Public Health Registries</td><td>Data from population-wide health data registries (Art. 51 1k).</td></tr><tr><td style="white-space:nowrap">medical-mortality-registry<a name="EUAIActCodeSystem-medical-mortality-registry"> </a></td><td>Medical and Mortality Registries</td><td>Data from medical registries and mortality registries (Art. 51 1l).</td></tr><tr><td style="white-space:nowrap">clinical-trial<a name="EUAIActCodeSystem-clinical-trial"> </a></td><td>Clinical Trial Data</td><td>Data from clinical trials, clinical studies and performance studies (Art. 51 1m).</td></tr><tr><td style="white-space:nowrap">medical-device-other<a name="EUAIActCodeSystem-medical-device-other"> </a></td><td>Other Medical Device Data</td><td>Other health data from medical devices (Art. 51 1n).</td></tr><tr><td style="white-space:nowrap">medicinal-device-registry<a name="EUAIActCodeSystem-medicinal-device-registry"> </a></td><td>Medicinal and Device Registries</td><td>Data from registries for medicinal products and medical devices (Art. 51 1o).</td></tr><tr><td style="white-space:nowrap">research-cohort-survey<a name="EUAIActCodeSystem-research-cohort-survey"> </a></td><td>Research Cohorts and Surveys</td><td>Data from research cohorts, questionnaires and health-related surveys (Art. 51 1p).</td></tr><tr><td style="white-space:nowrap">biobank<a name="EUAIActCodeSystem-biobank"> </a></td><td>Biobank Data</td><td>Health data from biobanks and associated databases (Art. 51 1q).</td></tr><tr><td style="white-space:nowrap">representative<a name="EUAIActCodeSystem-representative"> </a></td><td>Representative</td><td>Data are sufficiently representative of the target population.</td></tr><tr><td style="white-space:nowrap">error-free<a name="EUAIActCodeSystem-error-free"> </a></td><td>Error-Free</td><td>Data are free of errors to the best extent possible.</td></tr><tr><td style="white-space:nowrap">complete<a name="EUAIActCodeSystem-complete"> </a></td><td>Complete</td><td>Data are complete with regard to the intended purpose.</td></tr><tr><td style="white-space:nowrap">relevant<a name="EUAIActCodeSystem-relevant"> </a></td><td>Relevant</td><td>Data are relevant for the intended purpose.</td></tr></table></div>
</text>
<url
value="http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"/>
<version value="0.1.0"/>
<name value="EUAIActCodeSystem"/>
<title value="EU AI Transparency Custom Codes"/>
<status value="active"/>
<experimental value="false"/>
<date value="2026-06-18T11:52:19+00:00"/>
<publisher value="Selina Adlberger"/>
<description
value="Custom codes used in this IG to represent AI transparency, data-use, provenance, technical documentation, data-quality, and human-oversight documentation concepts."/>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="55"/>
<concept>
<code value="ai-system"/>
<display value="AI System"/>
</concept>
<concept>
<code value="high-risk-ai"/>
<display value="High-Risk AI System"/>
</concept>
<concept>
<code value="gpai"/>
<display value="General Purpose AI"/>
</concept>
<concept>
<code value="model-card"/>
<display value="AI Model Card"/>
</concept>
<concept>
<code value="ai-generated"/>
<display value="AI Generated Result"/>
</concept>
<concept>
<code value="human-override"/>
<display value="Human Override"/>
</concept>
<concept>
<code value="human-validation"/>
<display value="Human Validation"/>
</concept>
<concept>
<code value="human-correction"/>
<display value="Human Correction"/>
</concept>
<concept>
<code value="ai-transparency-info"/>
<display value="AI Transparency Information"/>
</concept>
<concept>
<code value="patient-information-provided"/>
<display value="Patient Information Provided"/>
</concept>
<concept>
<code value="patient-explanation-requested"/>
<display value="Patient Explanation Requested"/>
</concept>
<concept>
<code value="patient-explanation-provided"/>
<display value="Patient Explanation Provided"/>
</concept>
<concept>
<code value="accuracy"/>
<display value="Accuracy"/>
</concept>
<concept>
<code value="sensitivity"/>
<display value="Sensitivity"/>
</concept>
<concept>
<code value="specificity"/>
<display value="Specificity"/>
</concept>
<concept>
<code value="robustness"/>
<display value="Robustness"/>
</concept>
<concept>
<code value="clinically-validated"/>
<display value="Clinically Validated"/>
<definition value="The AI system has completed clinical validation."/>
</concept>
<concept>
<code value="not-clinically-validated"/>
<display value="Not Clinically Validated"/>
<definition value="The AI system has not completed clinical validation."/>
</concept>
<concept>
<code value="validation-in-progress"/>
<display value="Validation In Progress"/>
<definition value="Clinical validation is currently in progress."/>
</concept>
<concept>
<code value="technical-validation-only"/>
<display value="Technical Validation Only"/>
<definition
value="Only technical or syntactic validation has been performed."/>
</concept>
<concept>
<code value="triage"/>
<display value="Triage and Prioritization"/>
</concept>
<concept>
<code value="screening"/>
<display value="Screening"/>
</concept>
<concept>
<code value="second-opinion"/>
<display value="Second Opinion"/>
</concept>
<concept>
<code value="diagnostic-support"/>
<display value="Diagnostic Support"/>
</concept>
<concept>
<code value="treatment-planning"/>
<display value="Treatment Planning"/>
</concept>
<concept>
<code value="prognosis"/>
<display value="Prognostic Prediction"/>
</concept>
<concept>
<code value="ce-mark"/>
<display value="CE Mark"/>
<definition value="Indicates whether the device has a CE mark."/>
</concept>
<concept>
<code value="notified-body-id"/>
<display value="Notified Body ID"/>
<definition value="Identifier of the notified body."/>
</concept>
<concept>
<code value="expected-lifetime"/>
<display value="Expected Lifetime"/>
<definition value="The expected lifetime of the AI system."/>
</concept>
<concept>
<code value="medical-purpose"/>
<display value="Medical Purpose"/>
<definition value="The intended medical purpose."/>
</concept>
<concept>
<code value="target-population"/>
<display value="Target Population"/>
<definition value="The intended target population."/>
</concept>
<concept>
<code value="eu-ai-database-id"/>
<display value="EU AI Database Identifier"/>
<definition
value="Identifier for an AI system registration in the EU AI database or an equivalent AI system registry."/>
</concept>
<concept>
<code value="primary-use"/>
<display value="Primary Use"/>
<definition value="Processing for direct patient care."/>
</concept>
<concept>
<code value="secondary-use"/>
<display value="Secondary Use"/>
<definition
value="Processing for research, AI training, policy making, or other permitted secondary-use purposes."/>
</concept>
<concept>
<code value="ehr"/>
<display value="Electronic Health Records (EHRs)"/>
<definition
value="Electronic health data from electronic health records (Art. 51 1a)."/>
</concept>
<concept>
<code value="health-factors"/>
<display value="Health Determinants"/>
<definition
value="Data impacting health, including socioeconomic, environmental and behavioural determinants (Art. 51 1b)."/>
</concept>
<concept>
<code value="healthcare-resources"/>
<display value="Aggregated Healthcare Data"/>
<definition
value="Aggregated data on healthcare needs, resources, access and financing (Art. 51 1c)."/>
</concept>
<concept>
<code value="pathogen-data"/>
<display value="Pathogen Data"/>
<definition
value="Data on pathogens impacting human health (Art. 51 1d)."/>
</concept>
<concept>
<code value="admin-claims"/>
<display value="Administrative and Claims Data"/>
<definition
value="Health-related administrative data, including claims and reimbursement data (Art. 51 1e)."/>
</concept>
<concept>
<code value="human-genomic"/>
<display value="Human Genomic Data"/>
<definition
value="Human genetic, epigenomic and genomic data (Art. 51 1f)."/>
</concept>
<concept>
<code value="molecular-omics"/>
<display value="Molecular Omic Data"/>
<definition
value="Other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data (Art. 51 1g)."/>
</concept>
<concept>
<code value="device-generated-personal"/>
<display value="Device-Generated Personal Data"/>
<definition
value="Person-generated electronic health data automatically generated by medical devices (Art. 51 1h)."/>
</concept>
<concept>
<code value="wellness-apps"/>
<display value="Wellness Application Data"/>
<definition value="Data from wellness applications (Art. 51 1i)."/>
</concept>
<concept>
<code value="professional-status"/>
<display value="Healthcare Professional Data"/>
<definition
value="Data on the professional status, specialization and institution of healthcare professionals (Art. 51 1j)."/>
</concept>
<concept>
<code value="public-health-registry"/>
<display value="Public Health Registries"/>
<definition
value="Data from population-wide health data registries (Art. 51 1k)."/>
</concept>
<concept>
<code value="medical-mortality-registry"/>
<display value="Medical and Mortality Registries"/>
<definition
value="Data from medical registries and mortality registries (Art. 51 1l)."/>
</concept>
<concept>
<code value="clinical-trial"/>
<display value="Clinical Trial Data"/>
<definition
value="Data from clinical trials, clinical studies and performance studies (Art. 51 1m)."/>
</concept>
<concept>
<code value="medical-device-other"/>
<display value="Other Medical Device Data"/>
<definition value="Other health data from medical devices (Art. 51 1n)."/>
</concept>
<concept>
<code value="medicinal-device-registry"/>
<display value="Medicinal and Device Registries"/>
<definition
value="Data from registries for medicinal products and medical devices (Art. 51 1o)."/>
</concept>
<concept>
<code value="research-cohort-survey"/>
<display value="Research Cohorts and Surveys"/>
<definition
value="Data from research cohorts, questionnaires and health-related surveys (Art. 51 1p)."/>
</concept>
<concept>
<code value="biobank"/>
<display value="Biobank Data"/>
<definition
value="Health data from biobanks and associated databases (Art. 51 1q)."/>
</concept>
<concept>
<code value="representative"/>
<display value="Representative"/>
<definition
value="Data are sufficiently representative of the target population."/>
</concept>
<concept>
<code value="error-free"/>
<display value="Error-Free"/>
<definition value="Data are free of errors to the best extent possible."/>
</concept>
<concept>
<code value="complete"/>
<display value="Complete"/>
<definition
value="Data are complete with regard to the intended purpose."/>
</concept>
<concept>
<code value="relevant"/>
<display value="Relevant"/>
<definition value="Data are relevant for the intended purpose."/>
</concept>
</CodeSystem>