Brazil implements new regulations for AI in medicine

New regulations governing the use of Artificial Intelligence (AI) in medicine, established by the Federal Council of Medicine (CFM) through Resolution No. 2.454/2026, entered into force on Wednesday, August 26, 2026.

The resolution mandates that AI must function strictly as a support tool. Final responsibility for clinical, diagnostic, therapeutic, and prognostic decisions remains solely with the physician. Medical professionals are required to critically evaluate AI recommendations and are protected from punishment if they choose to override an algorithm based on their technical and ethical judgment.

Key provisions include: - Patient Rights: Patients must be informed when AI plays a relevant role in their care and have the right to informed refusal of such technology. - Human Mediation: Doctors are prohibited from using automated systems to communicate diagnoses, prognoses, or therapeutic decisions without human intervention. - Documentation and Governance: The use of AI must be recorded in medical records, and healthcare institutions must implement strict data security, monitoring, and governance protocols.

The rules apply nationwide and cover systems that were already in use or under development at the time the regulation took effect.