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

Health Policy, volume 149, 2024 [10.1016/j.healthpol.2024.105152]

9 Pages Posted: 29 Aug 2024

See all articles by Hannah van Kolfschooten

Hannah van Kolfschooten

Law Centre for Health and Life; University of Amsterdam - Amsterdam Centre for European Law and Governance; Amsterdam Law School

Janneke van Oirschot

Health Action International

Date Written: August 01, 2024

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.

Keywords: AI act, Artificial Intelligence Act, AIA, AI in healthcare, health law, EU law, doctors, health professionals, health AI, medical AI, regulation, AI regulation, medical law, technology, medtech, medical devices, AI devices, AI medical devices, AI systems, AI ethics, AI law, human rights, health rights, European Commission

Suggested Citation

van Kolfschooten, Hannah and van Oirschot, Janneke, The EU Artificial Intelligence Act (2024): Implications for Healthcare (August 01, 2024). Health Policy, volume 149, 2024 [10.1016/j.healthpol.2024.105152], Available at SSRN: https://ssrn.com/abstract=4939395 or http://dx.doi.org/10.1016/j.healthpol.2024.105152

Hannah Van Kolfschooten (Contact Author)

Law Centre for Health and Life ( email )

Nieuwe Achtergracht 166
Amsterdam, 1018 WV
Netherlands

University of Amsterdam - Amsterdam Centre for European Law and Governance ( email )

P.O.Box 1030
Amsterdam, 1000 BA
Netherlands

Amsterdam Law School ( email )

Amsterdam, 1018 WB
Netherlands

Janneke Van Oirschot

Health Action International ( email )

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