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） 的监管框架来降低风险，同时确保在医疗保健和人口健康中以合乎道德、安全和有效的方式实施 AI 技术。在本文中，我们综合了 141 项适用于欧盟和 10 个欧洲国家在医疗保健和人口健康领域的 AI 的约束性政策。欧盟 AI 法案设定了 AI 的整体监管框架，而其他立法则设定了社会、健康和人权标准，解决了技术安全和创新的实施问题，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人工智能在健康领域的基线监管框架，但专门与 AI 相关的监管仍处于起步阶段且稀缺。未来的工作应探索具体的监管挑战，尤其是在 AI 医疗设备、数据保护和数据支持方面。