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The EU Artificial Intelligence Act (2024): Implications for healthcare

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  • van Kolfschooten, Hannah
  • van Oirschot, Janneke

Abstract

In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world's first extensive legal framework on AI, it aims to boost innovation while protecting individuals against the harms of AI. Since healthcare is one of the top sectors for AI deployment, the new rules will significantly reform national policies and practices on health technology. In this article, we highlight the implications of the AI Act for the healthcare sector. We give a comprehensive overview of the new legal obligations for various healthcare stakeholders (tech developers; healthcare professionals; public health authorities). We conclude that, due to its horizontal approach, it is necessary to adopt further guidelines to address the unique needs of the healthcare sector. To this end, we make recommendations for the upcoming implementation and standardization phase.

Suggested Citation

  • van Kolfschooten, Hannah & van Oirschot, Janneke, 2024. "The EU Artificial Intelligence Act (2024): Implications for healthcare," Health Policy, Elsevier, vol. 149(C).
    • Handle: RePEc:eee:hepoli:v:149:y:2024:i:c:s0168851024001623
    DOI: 10.1016/j.healthpol.2024.105152
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    References listed on IDEAS

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    1. Karan Singhal & Shekoofeh Azizi & Tao Tu & S. Sara Mahdavi & Jason Wei & Hyung Won Chung & Nathan Scales & Ajay Tanwani & Heather Cole-Lewis & Stephen Pfohl & Perry Payne & Martin Seneviratne & Paul G, 2023. "Publisher Correction: Large language models encode clinical knowledge," Nature, Nature, vol. 620(7973), pages 19-19, August.
    2. Karan Singhal & Shekoofeh Azizi & Tao Tu & S. Sara Mahdavi & Jason Wei & Hyung Won Chung & Nathan Scales & Ajay Tanwani & Heather Cole-Lewis & Stephen Pfohl & Perry Payne & Martin Seneviratne & Paul G, 2023. "Large language models encode clinical knowledge," Nature, Nature, vol. 620(7972), pages 172-180, August.
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    Cited by:

    1. RAHAL, Imen & Khalifa, Zayed, 2025. "Artificial Intelligence and Economic Growth: Opportunities, Challenges, and Future Directions," MPRA Paper 127061, University Library of Munich, Germany, revised 12 Nov 2025.

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