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