Artificial Intelligence (AI) has led to transformations in various sectors, especially in healthcare, with the application of intelligent medical records, robots and virtual assistants that help with medical procedures.

The National Congress, with bill (PL)  2.338/23intends to regulate the use of AI. Currently before the Federal Senate, the AI Legal Framework establishes national standards for the development, implementation and responsible use of AI systems, in order to protect fundamental rights and guarantee the implementation of safe and reliable systems

Applications in the health sector were classified by the PL as high risk. It will therefore be necessary to establish governance structures and internal procedures to guarantee the security of the systems and compliance with the rights of affected users.

On November 28th, 2023, the Substitute PL of the AI Legal Framework was published, with 22 articles, which removed the classification of health applications as high-risk. Instead, it mentions health impacts among the factors that contribute to the impact assessment of AI.