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 |
{
"resourceType" : "CodeSystem",
"id" : "EUAIActCodeSystem",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"url" : "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem",
"version" : "0.1.0",
"name" : "EUAIActCodeSystem",
"title" : "EU AI Transparency Custom Codes",
"status" : "active",
"experimental" : false,
"date" : "2026-06-18T12:04:51+00:00",
"publisher" : "Selina Adlberger",
"description" : "Custom codes used in this IG to represent AI transparency, data-use, provenance, technical documentation, data-quality, and human-oversight documentation concepts.",
"caseSensitive" : true,
"content" : "complete",
"count" : 55,
"concept" : [
{
"code" : "ai-system",
"display" : "AI System"
},
{
"code" : "high-risk-ai",
"display" : "High-Risk AI System"
},
{
"code" : "gpai",
"display" : "General Purpose AI"
},
{
"code" : "model-card",
"display" : "AI Model Card"
},
{
"code" : "ai-generated",
"display" : "AI Generated Result"
},
{
"code" : "human-override",
"display" : "Human Override"
},
{
"code" : "human-validation",
"display" : "Human Validation"
},
{
"code" : "human-correction",
"display" : "Human Correction"
},
{
"code" : "ai-transparency-info",
"display" : "AI Transparency Information"
},
{
"code" : "patient-information-provided",
"display" : "Patient Information Provided"
},
{
"code" : "patient-explanation-requested",
"display" : "Patient Explanation Requested"
},
{
"code" : "patient-explanation-provided",
"display" : "Patient Explanation Provided"
},
{
"code" : "accuracy",
"display" : "Accuracy"
},
{
"code" : "sensitivity",
"display" : "Sensitivity"
},
{
"code" : "specificity",
"display" : "Specificity"
},
{
"code" : "robustness",
"display" : "Robustness"
},
{
"code" : "clinically-validated",
"display" : "Clinically Validated",
"definition" : "The AI system has completed clinical validation."
},
{
"code" : "not-clinically-validated",
"display" : "Not Clinically Validated",
"definition" : "The AI system has not completed clinical validation."
},
{
"code" : "validation-in-progress",
"display" : "Validation In Progress",
"definition" : "Clinical validation is currently in progress."
},
{
"code" : "technical-validation-only",
"display" : "Technical Validation Only",
"definition" : "Only technical or syntactic validation has been performed."
},
{
"code" : "triage",
"display" : "Triage and Prioritization"
},
{
"code" : "screening",
"display" : "Screening"
},
{
"code" : "second-opinion",
"display" : "Second Opinion"
},
{
"code" : "diagnostic-support",
"display" : "Diagnostic Support"
},
{
"code" : "treatment-planning",
"display" : "Treatment Planning"
},
{
"code" : "prognosis",
"display" : "Prognostic Prediction"
},
{
"code" : "ce-mark",
"display" : "CE Mark",
"definition" : "Indicates whether the device has a CE mark."
},
{
"code" : "notified-body-id",
"display" : "Notified Body ID",
"definition" : "Identifier of the notified body."
},
{
"code" : "expected-lifetime",
"display" : "Expected Lifetime",
"definition" : "The expected lifetime of the AI system."
},
{
"code" : "medical-purpose",
"display" : "Medical Purpose",
"definition" : "The intended medical purpose."
},
{
"code" : "target-population",
"display" : "Target Population",
"definition" : "The intended target population."
},
{
"code" : "eu-ai-database-id",
"display" : "EU AI Database Identifier",
"definition" : "Identifier for an AI system registration in the EU AI database or an equivalent AI system registry."
},
{
"code" : "primary-use",
"display" : "Primary Use",
"definition" : "Processing for direct patient care."
},
{
"code" : "secondary-use",
"display" : "Secondary Use",
"definition" : "Processing for research, AI training, policy making, or other permitted secondary-use purposes."
},
{
"code" : "ehr",
"display" : "Electronic Health Records (EHRs)",
"definition" : "Electronic health data from electronic health records (Art. 51 1a)."
},
{
"code" : "health-factors",
"display" : "Health Determinants",
"definition" : "Data impacting health, including socioeconomic, environmental and behavioural determinants (Art. 51 1b)."
},
{
"code" : "healthcare-resources",
"display" : "Aggregated Healthcare Data",
"definition" : "Aggregated data on healthcare needs, resources, access and financing (Art. 51 1c)."
},
{
"code" : "pathogen-data",
"display" : "Pathogen Data",
"definition" : "Data on pathogens impacting human health (Art. 51 1d)."
},
{
"code" : "admin-claims",
"display" : "Administrative and Claims Data",
"definition" : "Health-related administrative data, including claims and reimbursement data (Art. 51 1e)."
},
{
"code" : "human-genomic",
"display" : "Human Genomic Data",
"definition" : "Human genetic, epigenomic and genomic data (Art. 51 1f)."
},
{
"code" : "molecular-omics",
"display" : "Molecular Omic Data",
"definition" : "Other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data (Art. 51 1g)."
},
{
"code" : "device-generated-personal",
"display" : "Device-Generated Personal Data",
"definition" : "Person-generated electronic health data automatically generated by medical devices (Art. 51 1h)."
},
{
"code" : "wellness-apps",
"display" : "Wellness Application Data",
"definition" : "Data from wellness applications (Art. 51 1i)."
},
{
"code" : "professional-status",
"display" : "Healthcare Professional Data",
"definition" : "Data on the professional status, specialization and institution of healthcare professionals (Art. 51 1j)."
},
{
"code" : "public-health-registry",
"display" : "Public Health Registries",
"definition" : "Data from population-wide health data registries (Art. 51 1k)."
},
{
"code" : "medical-mortality-registry",
"display" : "Medical and Mortality Registries",
"definition" : "Data from medical registries and mortality registries (Art. 51 1l)."
},
{
"code" : "clinical-trial",
"display" : "Clinical Trial Data",
"definition" : "Data from clinical trials, clinical studies and performance studies (Art. 51 1m)."
},
{
"code" : "medical-device-other",
"display" : "Other Medical Device Data",
"definition" : "Other health data from medical devices (Art. 51 1n)."
},
{
"code" : "medicinal-device-registry",
"display" : "Medicinal and Device Registries",
"definition" : "Data from registries for medicinal products and medical devices (Art. 51 1o)."
},
{
"code" : "research-cohort-survey",
"display" : "Research Cohorts and Surveys",
"definition" : "Data from research cohorts, questionnaires and health-related surveys (Art. 51 1p)."
},
{
"code" : "biobank",
"display" : "Biobank Data",
"definition" : "Health data from biobanks and associated databases (Art. 51 1q)."
},
{
"code" : "representative",
"display" : "Representative",
"definition" : "Data are sufficiently representative of the target population."
},
{
"code" : "error-free",
"display" : "Error-Free",
"definition" : "Data are free of errors to the best extent possible."
},
{
"code" : "complete",
"display" : "Complete",
"definition" : "Data are complete with regard to the intended purpose."
},
{
"code" : "relevant",
"display" : "Relevant",
"definition" : "Data are relevant for the intended purpose."
}
]
}