Schmidt Jelena, Schutte Nienke M, Buttigieg Stefan, Novillo-Ortiz David, Sutherland Eric, Anderson Michael, de Witte Bart, Peolsson Michael, Unim Brigid, Pavlova Milena, Stern Ariel Dora, Mossialos Elias, van Kessel Robin
Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
Innovation in Health Information Systems Unit, SD Data Governance, Sciensano, Brussels, Belgium.
NPJ Digit Med. 2024 Aug 27;7(1):229. doi: 10.1038/s41746-024-01221-6.
Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement.
需要人工智能（AI）监管框架来降低风险，同时确保AI技术在医疗保健和人群健康领域的道德、安全和有效实施。在本文中，我们综合了适用于欧盟及10个欧洲国家医疗保健和人群健康领域AI的141项具有约束力的政策。欧盟AI法案为AI设定了总体监管框架，而其他立法设定了社会、健康和人权标准，涉及技术安全和创新实施，并确保数据的保护和安全使用。尽管数据、技术、创新以及健康和人权政策的结合已经形成了健康领域AI的基线监管框架，但专门针对AI的监管仍处于起步阶段且较为稀少。未来的工作应探索具体的监管挑战，特别是在AI医疗设备、数据保护和数据赋能方面。
