Brazil creates first rule for AI in medicine: diagnosis cannot be automatic and patients may refuse use
Brazil's Federal Medical Council has established its first specific guideline governing the use of artificial intelligence in medical practice, emphasizing that AI must serve as a supportive tool rather than a replacement for human clinical judgment.
On September 27, Brazil's Federal Medical Council announced a groundbreaking regulation concerning the application of artificial intelligence (AI) in the medical field. The newly introduced rule, published in the official government gazette, stipulates that AI technologies are to support medical decisions but must never replace the clinician's judgment. This initiative marks a pioneering step in ensuring that human oversight remains central to patient care, acknowledging that while AI can assist in diagnostics and treatment planning, the ultimate responsibility lies solely with the healthcare professional.
The regulations also explicitly state that healthcare providers are not mandated to adhere strictly to AI recommendations, ensuring that physicians maintain their autonomy in clinical decision-making. Additionally, AI systems are prohibited from communicating diagnoses or therapeutic decisions to patients without human mediation. This provision underscores the importance of human interaction in healthcare, prioritizing patient understanding and consent before any AI-derived information is conveyed. As AI continues to advance, these stipulations are crucial in balancing technological innovation with the ethical obligations of medical practice.
The new guideline will take effect in 180 days, urging healthcare professionals and institutions to adapt their practices to comply with these standards. The rule not only aims to mitigate potential risks associated with reliance on AI but also opens avenues for utilizing AI in clinical decision-making, health management, medical research, and ongoing education. This step reflects Brazil's commitment to harnessing technology responsibly in the healthcare sector while ensuring that patients' rights and safety are preserved.