Brasília – The Ministry of Health hosted on Tuesday (2) a seminar to debate Bill 2.338/2023, which proposes the regulation of artificial intelligence in Brazil. The discussion focused on the bill’s scope, legislative process, and potential impacts on the health sector. Already approved by the Senate, the proposal is now under review in the Chamber of Deputies.

The legislation establishes national guidelines for the use of AI, defining responsibilities and ensuring rights for the population. AI systems applied in health — such as those assisting in diagnostics or medical procedures — would be classified as high-risk when significant risks to physical or mental integrity exist. This classification requires stricter criteria, including human supervision, testing protocols, and measures to mitigate discriminatory bias.

Ana Estela Haddad, Secretary of Information and Digital Health, praised the Senate’s version as “very good,” noting its provisions on risk minimization, human oversight, and accountability. She emphasized that the government’s role has been to align the bill with other federal initiatives supporting sovereign infrastructure.

Parliamentarians participating in the event highlighted the urgency of moving the bill forward before the 2026 elections. Federal Deputy Aguinaldo Ribeiro, rapporteur of the bill in the Chamber, stated: “We are working for swift approval in constant dialogue with the government. The Senate did an important job in approving a solid text, and now our goal is to refine it to ensure patient safety.”

Next steps include the designation of a central AI regulatory body, supported by sectoral regulators. In health, Anvisa and ANS are expected to be responsible for oversight, enforcement, and sanctioning related to AI systems.

Source: Futuro da Saúde

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