AI in medicine: CFM resolution comes into force, but doubts remain

The entry into force of CFM Resolution No. 2,454/2026, which regulates the use of artificial intelligence in medical practice in Brazil, establishes parameters for the use of AI by physicians while raising questions about implementation and the limits of the Federal Council of Medicine’s normative competence. This article discusses the interaction between the resolution and the broader Brazilian legal framework, including data protection, patients’ rights, and the regulation of software as a medical device. It also highlights practical challenges concerning patient information, consent, accountability, auditing, transparency, and AI literacy.