 0 Table of Contents |
  1 Home |
  2 Profiles |
  3 Extensions |
  4 Terminology |
  5 Examples |
  6 Dependencies |
  7 Intellectual Property |
  8 Artifacts Summary |
   8.1 EU AI Act Model Card |
   8.2 EU AI Execution Audit Event |
   8.3 EU AI Generated Observation |
   8.4 EU AI Human Oversight Assessment |
   8.5 EU AI Patient Explanation Communication |
   8.6 EU AI Practitioner Role |
   8.7 EU AI Provenance |
   8.8 EU AI Responsible Organization |
   8.9 EU AI System Device |
   8.10 AI Clinical Validation Status |
   8.11 AI Performance Metrics |
   8.12 AI Retention Information |
   8.13 AI System-Specific Training Status |
   8.14 AI Training Data Metadata |
   8.15 Automated Decision-Making Flag |
   8.16 Case-Specific Indication |
   8.17 EHDS Data Permit |
   8.18 EHDS Secondary Use Purpose |
   8.19 EHDS Usage Category |
   8.20 EU AI Log Integrity Signature |
   8.21 Model Card Reference |
   8.22 Third-Country Data Transfer |
   8.23 EHDS Data Category Value Set |
   8.24 EHDS Secondary-Use Purpose Value Set |
   8.25 EHDS Usage Category Value Set |
   8.26 EU AI Audit Entity Role Value Set |
   8.27 EU AI Case-Specific Indication Value Set |
   8.28 EU AI Clinical Validation Status Value Set |
   8.29 EU AI Data Quality Value Set |
   8.30 EU AI Human Oversight Action Value Set |
   8.31 EU AI Involvement Value Set |
   8.32 EU AI Performance Metric Value Set |
   8.33 GDPR Article 6 Legal Basis Value Set |
   8.34 GDPR Article 9 Condition Value Set |
   8.35 EHDS Data Category Code System |
   8.36 EHDS Secondary-Use Purpose Code System |
   8.37 EHDS Usage Category Code System |
   8.38 EU AI Artifact Type Code System |
   8.39 EU AI Audit Entity Role Code System |
   8.40 EU AI Case-Specific Indication Code System |
   8.41 EU AI Clinical Validation Status Code System |
   8.42 EU AI Contact Purpose Code System |
   8.43 EU AI Data Quality Code System |
   8.44 EU AI Human Oversight Code System |
   8.45 EU AI Identifier Type Code System |
   8.46 EU AI Involvement Code System |
   8.47 EU AI Performance Metric Code System |
   8.48 EU AI System Property Code System |
   8.49 GDPR Article 6 Legal Basis Code System |
   8.50 GDPR Article 9 Condition Code System |
   8.51 AI Output: Early Warning Risk Assessment (1) |
   8.52 AI Output: Early Warning Risk Assessment (2) |
   8.53 AI Output: Early Warning Risk Assessment (3) |
   8.54 AI Output: Early Warning Risk Assessment (4) |
   8.55 Assessment: Human Correction of AI Output (4) |
   8.56 Assessment: Human Override of AI Output (3) |
   8.57 Assessment: Human Validation of AI Output (2) |
   8.58 Audit Log: AI Execution Trace (1) |
   8.59 Audit Log: AI Execution Trace (2) |
   8.60 Audit Log: AI Execution Trace (3) |
   8.61 Audit Log: AI Execution Trace (4) |
   8.62 Communication: Patient-Facing AI Explanation (4) |
   8.63 Corrected Clinical Observation: Early Warning Risk Assessment (4) |
   8.64 Device: RiskAssist AI |
   8.65 Encounter: Acute Care Assessment |
   8.66 Input Observation: Blood Pressure (1) |
   8.67 Input Observation: Blood Pressure (2) |
   8.68 Input Observation: Blood Pressure (3) |
   8.69 Input Observation: Blood Pressure (4) |
   8.70 Input Observation: Body Temperature (1) |
   8.71 Input Observation: Body Temperature (2) |
   8.72 Input Observation: Body Temperature (3) |
   8.73 Input Observation: Body Temperature (4) |
   8.74 Input Observation: Consciousness Status (1) |
   8.75 Input Observation: Consciousness Status (2) |
   8.76 Input Observation: Consciousness Status (3) |
   8.77 Input Observation: Consciousness Status (4) |
   8.78 Input Observation: Heart Rate (1) |
   8.79 Input Observation: Heart Rate (2) |
   8.80 Input Observation: Heart Rate (3) |
   8.81 Input Observation: Heart Rate (4) |
   8.82 Input Observation: Oxygen Saturation (1) |
   8.83 Input Observation: Oxygen Saturation (2) |
   8.84 Input Observation: Oxygen Saturation (3) |
   8.85 Input Observation: Oxygen Saturation (4) |
   8.86 Input Observation: Respiratory Rate (1) |
   8.87 Input Observation: Respiratory Rate (2) |
   8.88 Input Observation: Respiratory Rate (3) |
   8.89 Input Observation: Respiratory Rate (4) |
   8.90 Manufacturer Organization: ExampleMed AI GmbH |
   8.91 Model Card: RiskAssist AI v1.0.0 |
   8.92 Operator Organization: Example Hospital |
   8.93 Patient: Synthetic Patient 001 |
   8.94 Practitioner: Human Reviewer |
   8.95 PractitionerRole: Human Reviewer |
   8.96 Provenance: AI Output Generation (1) |
   8.97 Provenance: AI Output Generation (2) |
   8.98 Provenance: AI Output Generation (3) |
   8.99 Provenance: AI Output Generation (4) |
   8.100 Provenance: Secondary Use Example |