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