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The EU AI Act: Implications for U.S. Health Care
Abstract
AbstractThe 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.
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The world's first AI act mandates responsible integration of AI in healthcare.
“The world's first AI act mandates responsible integration of AI in healthcare (Porsdam Mann, Cohen, and Minssen 2024)”
From Human-Clinical AI Agent Collaboration (2025) · cites this paper as Porsdam Mann, Cohen, and Minssen 2024
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Research works printed but not linked: 4
- Bradford A. The Brussels effect: how the European union rules the world. New York: Oxford Academic, 2019.
- 10.1108/JIC-05-2019-0113 · DOI
- 10.1111/ablj.12139 · DOI
- European Parliament, Directorate-General for Parliamentary Research Services. How the general data protection regulation changes the rules for scientific research. Brussels, Belgium: Publications Office, 2019.
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“The authors presented the potential to influence global medical AI policy and mentioned that U.S. healthcare stakeholders must engage proactively with this new regulatory framework to remain competitive and gain access to the EU market [11].”
Zand, J., Šuvakov, M., Overgaard, S., Kozikowski, C., Jimison, R. C., Nelson, K. B., Silvano, C. J., Meiners, L. M., Fan, J. W., Schultz, K. E., et al. (2026) · Mayo Clinic proceedings · doi:10.1016/j.mayocp.2025.11.008 · Cited by 3
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The Bidirectional Relationship Between XAI and Regulation: Operationalizing XAI for the AI Act
Hummel, A., Burden, H., Stenberg, S., Steghofer, J.-P., & Kühl, N. (2025) · doi:10.48550/arxiv.2505.20311 · Cited by 1
“Several studies have already addressed the question of how AI can be applied in healthcare, incorporating ethical and legal considerations [Aboy et al., 2024, Porsdam Mann et al., 2024, Karimian et al., 2022, Kiseleva et al., 2022].”
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“From a regulatory perspective, this necessitates clear liability frameworks and rigorous oversight mechanisms 80,81 .”
Position: EU AI Act's Research Exemptions Can Break the Publication Norms of Major AI Conferences
Wernick, A., & Meding, K. (2025) · doi:10.48550/arxiv.2506.03218
“…exceptions are usually discussed in connection with another topic, such as copyright or data protection (Quintais, 2024; Quezada-Tavarez et al., 2022; De Vries, 2021) or their relevance for a specific application area or type of AI (Bublitz et al., 2024; Mann et al., 2024; Hacker et al., 2023).”
Metadata
- Authors
- Porsdam Mann, S., Cohen, I. G., & Minssen, T.
- Affiliations
- Center for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Denmark
- Harvard University (US)
- University of Copenhagen (DK)
- Venue
- NEJM AI
- Publisher
- Massachusetts Medical Society
- Published
- 2024-10-24
- Volume
- 1
- Issue
- 11
- Pages
- AIp2400449-AIp2400449
- ISSN
- 2836-9386 (ISSN-L)
- OpenAlex
- W4403301089
- Cited by
- 17
- References
- 0
- Citations by year
- 2026: 4 · 2025: 13
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- NEJM AI (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Social Sciences › Law › Digitalization, Law, and Regulation
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Keywords
- EU AI Act, AI regulation, health care, United States health care system, artificial intelligence in healthcare
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