在欧盟范围内绘制卫生领域人工智能的监管格局
Jelena Schmidt1, Nienke M Schutte2, Stefan Buttigieg3,4
1Department of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
NPJ digital medicine
|August 27, 2024
概括
监管框架对于医疗保健中的人工智能 (AI) 是必不可少的. 欧盟对141项政策的审查揭示了健康领域人工智能的新兴但基础性的监管格局.
科学领域:
- 医疗保健政策 医疗保健政策
- 人工智能监管条例 人工智能监管条例
- 欧盟法律 欧盟法律
背景情况:
- 在医疗保健和人口健康方面有效实施人工智能 (AI) 需要强大的监管框架来管理风险并确保道德,安全和安全的使用.
- 欧盟和10个欧洲国家的现有政策为健康领域的人工智能形成了基准,尽管具体的人工智能监管仍在发展中.
研究的目的:
- 在欧盟和10个欧洲国家内,综合制定适用于人工智能 (AI) 在医疗保健和人口健康方面的有约束力的政策.
- 分析当前人工智能在健康领域的监管环境,确定现有的基础政策和未来发展领域.
主要方法:
- 141项具有约束力的政策的系统审查和综合.
- 分析欧盟人工智能法和涵盖社会,健康,人权,技术安全,创新和数据保护标准的补充立法.
主要成果:
- 欧盟人工智能法案为人工智能提供了一个总体的监管结构.
- 数据,技术,创新和健康/人权政策的结合,为健康领域的人工智能制定了基本的监管框架.
- 具体的AI监管仍处于新生阶段,现有的政策解决了AI实施的各个方面.
结论:
- 通过现有政策的结合,为健康领域的人工智能制定了基本的监管框架.
- 未来的研究应该解决人工智能医疗设备监管,数据保护和数据启用方面的具体挑战.
- 为了安全和道德的医疗保健应用,需要持续开发有针对性的AI法规.
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