WHO
Ethics and governance principles for protecting autonomy, safety, transparency, accountability, equity, and sustainability.
Primary guidance ↗AI Governance Frameworks
Compare healthcare AI frameworks by their purpose, scope and role in clinical practice.
Framework map
Five authorities, five different jobs
Responsible programs combine clinical ethics, risk management, quality systems, and the law that applies in each market. This comparison is educational and does not provide legal or regulatory advice.
NIST AI RMF
A voluntary risk management structure organized around Govern, Map, Measure, and Manage.
Primary guidance ↗FDA
Relevant when software functions may meet the definition of a regulated medical device in the United States.
FDA overview ↗AMA
Physician centered principles for augmented intelligence, clinical responsibility, transparency, and equitable use.
AMA resources ↗EU AI Act
A binding, risk based European law. Duties depend on the system, role, use, and implementation timetable; obtain qualified counsel for applicability.
European Commission ↗Translate principles into controls
| Decision | Minimum evidence | Operational control |
|---|---|---|
| Should we use it? | Intended use, affected population, alternatives, expected benefit | Named executive and clinical owners |
| Is it safe enough? | Local validation, subgroup performance, known failure modes | Human review and escalation thresholds |
| Is it still working? | Outcome, drift, override, complaint, and incident trends | Monitoring cadence, change control, pause authority |
Ask for concise conclusions, uncertainty, supporting sources, and the information needed to verify the result. Do not treat hidden reasoning as clinical evidence.
Apply the lifecycle gates →Selection Guide
Need help selecting a framework?
Discuss your intended use, clinical workflow and jurisdiction to identify relevant guidance and the questions that require specialist review.
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