The EU AI Act: Implications for U.S. Health Care

The European Union's Artificial Intelligence Act (AIA), which took effect on August 1, 2024, establishes the world's first comprehensive legal framework for AI, with significant implications for medical AI development and deployment worldwide. This article analyzes the AIA's key implications for physicians and medical innovators in the United States. We examine the Act's 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.