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pstrongAbstract: /strongThe European Unions Artificial Intelligence Act (AIA), which took effect on August 1, 2024, establishes the worlds first comprehensive legal framework for AI, with significant implications for medical AI development and deployment worldwide. This article analyzes the AIAs key implications for physicians and medical innovators in the United States. We examine the Acts risk-based approach, extraterritorial reach, and potential to influence global medical AI policy. We outline the key provisions of the AIA for medical AI systems and discuss its measures to support innovation. As implementation begins, U.S. health care stakeholders must engage proactively with this new regulatory landscape to remain competitive and gain access to the EU market./p
Mann et al. (Thu,) studied this question.