Gilbert Stephen
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany.
NPJ Digit Med. 2024 May 22;7(1):135. doi: 10.1038/s41746-024-01116-6.
On 13 March 2024, the much-anticipated AI Act was passed by the EU parliament and will soon be adopted as EU law. It will apply new requirements for developers and deployers of AI-enabled digital health tools (DHTs), including for a defined class of high-risk AI systems and for general-purpose AI. Although the text of the law is available, complete in all but the final checks of legal wording much is still not known about how the AI Act will affect the digital health landscape in the EU and beyond. The wording of many aspects of the Act is ambiguous, and often high-level objectives are stated, with the detail to come later in associated guidance, standards, and member state law and policy. It is also uncertain how the Act will intersect with pre-existing sector-specific legislation for medical AI. There are future steps in the legislative process that can clarify ambiguity, including standards, guidelines, and implementing laws, and the author remains optimistic the EU will get the implementation right.
2024年3月13日，备受期待的《人工智能法案》获欧盟议会通过，即将成为欧盟法律。该法案将对人工智能驱动的数字健康工具（DHT）的开发者和部署者提出新要求，包括针对特定类别的高风险人工智能系统以及通用人工智能。尽管法律文本已出台，除了最终的法律措辞检查外基本完备，但关于《人工智能法案》将如何影响欧盟及其他地区的数字健康格局，仍有许多未知之处。该法案许多方面的措辞模棱两可，通常只是阐述了高层次目标，具体细节将在相关指南、标准以及成员国法律和政策中进一步明确。此外，该法案将如何与现有的医疗人工智能领域特定立法相互交叉也尚不确定。立法进程还有后续步骤可以澄清这些模糊之处，包括标准、指南和实施法律，作者仍然乐观地认为欧盟会正确实施该法案。
