Navigating the European Union Artificial Intelligence Act for Healthcare
Felix Busch, Jakob Nikolas Kather, Christian Johner, Marina Moser, Daniel Truhn, Lisa C. Adams, Keno K. Bressem
Abstract
The European Union (EU) has taken a critical step towards regulating artificial intelligence (AI) with the adoption of the AI Act by its 27 member states on March 13, 2024 1 . First proposed in April 2021 by the European Commission 2 , the AI Act emerged from the growing recognition of AI’s transformative potential and the need to address associated risks and ethical concerns, building on previous EU initiatives, including the 2018 Coordinated Plan on AI 3 and the 2020 White Paper on AI 4 . The Council issued its position in December 2022 5 , followed by the European Parliament’s adoption of its negotiating position in June 2023 6 . After revising the draft, the final negotiations between the Commission and Council resulted in a provisional agreement in December 2023, which was endorsed by Member States in February 2024 1 .