0.1.0 - ci-build

TrustAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Table of Contents

.. 0 Table of Contents
... 1 Home
... 2 Introduction
... 3 Use Cases & Examples
... 4 Use Case 1 - AI-supported Risk evaluation
... 5 Use Case 2 - AI-generated Diagnostic Report
... 6 Requirements Traceability
... 7 Profiles
... 8 Extensions
... 9 Terminology
... 10 Authors and Contributors
... 11 Dependencies
... 12 Intellectual Property
... 13 Artifacts Summary
.... 13.1 AI Output: Diagnostic Report
.... 13.2 ArtifactAssessment: Human Validation
.... 13.3 AuditEvent: AI Diagnostic Report Generation
.... 13.4 Communication: Patient Explanation
.... 13.5 Device: DiagnosticAssist AI
.... 13.6 EU Conformity Declaration
.... 13.7 Input Observation: C-Reactive Protein
.... 13.8 Model Card: DiagnosticAssist AI
.... 13.9 Organization: Example Diagnostic Center
.... 13.10 Patient: Diagnostic Report Scenario
.... 13.11 Practitioner: Diagnostic Reviewer
.... 13.12 PractitionerRole: Diagnostic Reviewer
.... 13.13 Provenance: AI Diagnostic Report
.... 13.14 AI Output: Early Warning Risk Assessment (1)
.... 13.15 AI Output: Early Warning Risk Assessment (2)
.... 13.16 AI Output: Early Warning Risk Assessment (3)
.... 13.17 AI Output: Early Warning Risk Assessment (4)
.... 13.18 Assessment: Human Correction of AI Output (4)
.... 13.19 Assessment: Human Override of AI Output (3)
.... 13.20 Assessment: Human Validation of AI Output (2)
.... 13.21 Audit Log: AI Execution Trace (1)
.... 13.22 Audit Log: AI Execution Trace (2)
.... 13.23 Audit Log: AI Execution Trace (3)
.... 13.24 Audit Log: AI Execution Trace (4)
.... 13.25 Communication: Patient-Facing AI Explanation (4)
.... 13.26 Corrected Clinical Observation: Early Warning Risk Assessment (4)
.... 13.27 Device: RiskAssist AI
.... 13.28 Encounter: Acute Care Assessment
.... 13.29 EU Conformity Declaration
.... 13.30 Input Observation: Blood Pressure (1)
.... 13.31 Input Observation: Blood Pressure (2)
.... 13.32 Input Observation: Blood Pressure (3)
.... 13.33 Input Observation: Blood Pressure (4)
.... 13.34 Input Observation: Body Temperature (1)
.... 13.35 Input Observation: Body Temperature (2)
.... 13.36 Input Observation: Body Temperature (3)
.... 13.37 Input Observation: Body Temperature (4)
.... 13.38 Input Observation: Consciousness Status (1)
.... 13.39 Input Observation: Consciousness Status (2)
.... 13.40 Input Observation: Consciousness Status (3)
.... 13.41 Input Observation: Consciousness Status (4)
.... 13.42 Input Observation: Heart Rate (1)
.... 13.43 Input Observation: Heart Rate (2)
.... 13.44 Input Observation: Heart Rate (3)
.... 13.45 Input Observation: Heart Rate (4)
.... 13.46 Input Observation: Oxygen Saturation (1)
.... 13.47 Input Observation: Oxygen Saturation (2)
.... 13.48 Input Observation: Oxygen Saturation (3)
.... 13.49 Input Observation: Oxygen Saturation (4)
.... 13.50 Input Observation: Respiratory Rate (1)
.... 13.51 Input Observation: Respiratory Rate (2)
.... 13.52 Input Observation: Respiratory Rate (3)
.... 13.53 Input Observation: Respiratory Rate (4)
.... 13.54 Manufacturer Organization: ExampleMed AI GmbH
.... 13.55 Model Card: RiskAssist AI v1.0.0
.... 13.56 Operator Organization: Example Hospital
.... 13.57 Patient: Synthetic Patient 001
.... 13.58 Practitioner: Human Reviewer
.... 13.59 PractitionerRole: Human Reviewer
.... 13.60 Provenance: AI Output Generation (1)
.... 13.61 Provenance: AI Output Generation (2)
.... 13.62 Provenance: AI Output Generation (3)
.... 13.63 Provenance: AI Output Generation (4)
.... 13.64 Provenance: Secondary Use Example
.... 13.65 Trust AI Data
.... 13.66 Trust AI Execution Audit Event
.... 13.67 Trust AI Generated Observation
.... 13.68 Trust AI Human Oversight Assessment
.... 13.69 Trust AI Model Card
.... 13.70 Trust AI Patient Explanation Communication
.... 13.71 Trust AI Practitioner Role
.... 13.72 Trust AI Provenance
.... 13.73 Trust AI Responsible Organization
.... 13.74 Trust AI System Device
.... 13.75 AI Clinical Validation Status
.... 13.76 AI Performance Metrics
.... 13.77 AI Retention Information
.... 13.78 AI System-Specific Training Status
.... 13.79 AI Training Data Metadata
.... 13.80 Automated Decision-Making Flag
.... 13.81 Case-Specific Indication
.... 13.82 Data Permit
.... 13.83 EU Conformity Declaration Reference
.... 13.84 Model Card Reference
.... 13.85 Patient AI Info Provided Flag
.... 13.86 Secondary Use Purpose
.... 13.87 Third-Country Data Transfer
.... 13.88 Trust AI DPIA Reference
.... 13.89 Trust AI Log Integrity Signature
.... 13.90 Usage Category
.... 13.91 Data Category Value Set
.... 13.92 GDPR Article 6 Legal Basis Value Set
.... 13.93 GDPR Article 9 Condition Value Set
.... 13.94 Secondary-Use Purpose Value Set
.... 13.95 Trust AI Audit Entity Role Value Set
.... 13.96 Trust AI Case-Specific Indication Value Set
.... 13.97 Trust AI Clinical Validation Status Value Set
.... 13.98 Trust AI Data Quality Value Set
.... 13.99 Trust AI Human Oversight Action Value Set
.... 13.100 Trust AI Involvement Value Set
.... 13.101 Trust AI Performance Metric Value Set
.... 13.102 Usage Category Value Set
.... 13.103 Data Category Code System
.... 13.104 GDPR Article 6 Legal Basis Code System
.... 13.105 GDPR Article 9 Condition Code System
.... 13.106 Secondary-Use Purpose Code System
.... 13.107 Trust AI Artifact Type Code System
.... 13.108 Trust AI Audit Entity Role Code System
.... 13.109 Trust AI Case-Specific Indication Code System
.... 13.110 Trust AI Clinical Validation Status Code System
.... 13.111 Trust AI Contact Purpose Code System
.... 13.112 Trust AI Data Quality Code System
.... 13.113 Trust AI Human Oversight Code System
.... 13.114 Trust AI Identifier Type Code System
.... 13.115 Trust AI Involvement Code System
.... 13.116 Trust AI Performance Metric Code System
.... 13.117 Trust AI System Property Code System
.... 13.118 Usage Category Code System