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The Implementation Guide defines profiles covering the complete lifecycle of AI-supported clinical decision making.
These profiles describe the AI system, responsible organizations, and technical documentation independently of a specific clinical execution.
Represents the AI system as an identifiable and versioned system component.
It includes metadata such as:
Represents organizations involved in the AI lifecycle, including manufacturers, deployers, and healthcare providers.
It may also contain contact information for:
Represents model-card documentation and technical documentation.
It references supporting documentation and contains structured metadata regarding:
These profiles document AI execution and legal traceability.
Represents AI-generated clinical findings.
Documents technical execution logs and integrity information.
Documents data lineage, legal basis, source data, and execution context.
Documents patient consent and AI-related transparency information.
These profiles document human oversight and patient communication.
Represents human validation, override, correction, and review of AI-generated outputs.
Represents the reviewing healthcare professional and associated AI-specific competencies.
Documents patient-facing explanations regarding AI-supported clinical decisions.