Law Centre for Health and Life, University of Amsterdam, the Netherlands; Amsterdam Institute for Global Health and Development, the Netherlands.
Health Action International, the Netherlands.
Health Policy. 2024 Nov;149:105152. doi: 10.1016/j.healthpol.2024.105152. Epub 2024 Sep 7.
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.
2024 年 8 月，欧盟人工智能法案（AI 法案）生效。这项具有法律约束力的文书为欧盟人工智能系统的开发、投放市场、投入使用和使用制定了规则。作为世界上第一个关于人工智能的广泛法律框架，它旨在促进创新，同时保护个人免受人工智能的伤害。由于医疗保健是人工智能部署的首要领域之一，新规则将对国家卫生技术政策和实践进行重大改革。在本文中，我们强调了人工智能法案对医疗保健部门的影响。我们全面概述了各种医疗保健利益相关者（技术开发者；医疗保健专业人员；公共卫生当局）的新法律义务。我们的结论是，由于其横向方法，有必要通过进一步的指导方针来解决医疗保健部门的独特需求。为此，我们为即将到来的实施和标准化阶段提出了建议。
