Summary
Regulates the use of artificial intelligence in medical practice in Brazil. The resolution treats AI as a support tool for medical practice, clinical decision-making, health management, research, and education; requires physicians to remain finally responsible for clinical, diagnostic, therapeutic, and prognostic decisions; requires patient disclosure when AI is used as relevant support in care, diagnosis, or treatment; requires preliminary risk classification, governance processes, human supervision, data protection, monitoring, and bias-mitigation measures for medical AI systems.
Healthcare Implications
Creates one of the clearest physician-facing AI governance frameworks in the international module. Brazilian physicians and medical institutions using or developing AI must preserve physician autonomy and final medical judgment, explain AI use to patients, document AI use in medical records when used for decision support, avoid delegating diagnosis or therapeutic communication to AI without human mediation, classify AI systems by risk, and implement internal governance and oversight for safety, quality, ethics, privacy, security, and bias mitigation.