CFM Regulates The Use Of AI In Medicine In A New Resolution

New regulation establishes guidelines for the research, development, governance, and use of artificial intelligence in medical practice, with a focus on safety, transparency, and accountability

The Federal Council of Medicine (CFM) published Resolution No. 2,454, dated February 11, 2026, in the Official Gazette on February 27, 2026, later amended on March 5, 2026. The Resolution establishes guidelines for the research, development, governance, and use of Artificial Intelligence (AI)-based systems and solutions within medical practice.

The Resolution arises in a context of increasing use of AI technologies in healthcare, particularly in activities related to diagnostic support, clinical data analysis, and medical decision-making. In light of this scenario, the CFM sought to establish parameters to ensure that such technologies are used in a safe, ethical, and responsible manner, preserving the quality of medical care and patient safety.

Among its main provisions, the Resolution sets out guidelines for different stages related to the use of AI in medicine, including research, development, implementation, governance, auditing, monitoring, and the training of involved professionals. The objective is to foster technological innovation in healthcare while ensuring that these tools are used in a transparent and reliable manner.

The Resolution also reinforces the importance of the autonomy of physicians and healthcare institutions in adopting these technologies, allowing professionals and organizations to use AI-based solutions according to their needs and specific contexts, provided that the ethical and technical principles set forth in the regulation are observed.

Another relevant aspect is the requirement for auditing and monitoring mechanisms for AI systems used in medical practice. These mechanisms must be proportionate to the potential impact of the technology on healthcare delivery, enabling the assessment of system performance and the identification of possible risks or failures.

The Resolution also highlights the importance of transparency in the use of these tools. AI systems must present scientific evidence demonstrating their effectiveness, accuracy, and safety, as well as provide clear information about their operation and limitations.

Finally, the Resolution encourages cooperation among healthcare institutions and professionals, promoting the sharing of knowledge and best practices.

Overall, CFM Resolution No. 2,454/2026 represents an important step forward in regulating the use of AI in medicine in Brazil, as it establishes guidelines aimed at balancing technological advancement with patient protection, professional responsibility, and adherence to the ethical principles governing medical practice. In this context, it reinforces that AI should be used as a tool to support medical work, without replacing human intervention, clinical analysis, and the professional judgment of the physician responsible for patient care.

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