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Regulation·FEB / 28 / 2026·12 min

CFM Resolution 2,454/2026: what changes for clinical AI.

A practical reading of Brazil's new rules for medical AI: governance, risk, human supervision, and audit evidence.

Dr. Petrus Bonfim

CFM Resolution 2,454/2026 is important because it stops treating AI as an abstract technology and starts treating it as a clinical instrument. It defines responsibilities, documentation duties, and the physician's final accountability.

Meaningful human supervision is the center.

The AI can organize, suggest, and document. It cannot sign, diagnose, or replace judgment. The radiologist must be able to inspect the output, disagree with it, edit it, and leave a clear record of the final clinical decision.

  • The final document should make AI use traceable.
  • Model version and user edits need to be auditable.
  • Higher-risk workflows need proportional governance.
  • Institutional policies and contingency plans matter.
AI is an instrument. The physician who signs remains responsible.

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