Regulatory baselines
Separate the rules governing an insurer’s use of AI from the rules governing an insured vendor or clinical deployment. They can involve different purposes, jurisdictions, documentation, decision owners and authorities. STABLE
Classify before mapping
Section titled “Classify before mapping”Determine the system’s intended use, users, outputs, actions, jurisdiction, and relevant product category. Then obtain the applicable official requirements and expert review. Do not apply medical-device obligations to every healthcare assistant or treat every insurance AI system as high risk. VERIFY the current FDA, MHRA, EU and local requirements for the actual deployment.
A declared baseline can incorporate relevant controls and approved operating conditions. A framework crosswalk helps locate evidence but cannot establish that all requirements are met. Runtime execution evidence supports only the named control and observed scope. STABLE
Clinical adequacy, privacy, data quality, human review and safety need their own assessment. Reusing an evidence packet across an audit and underwriting review is a possible workflow benefit, subject to each reviewer accepting its relevance and access terms. STABLE
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