人工智能医疗器械的监管响应和批准状况,重点关注中国
Yuehua Liu1, Wenjin Yu2, Tharam Dillon3
1School of Computer Engineering and Science, Shanghai University, Shanghai, China.
NPJ digital medicine
|September 18, 2024
概括
与中国不同的是,美国和欧盟的监管机构更倾向于对支持人工智能 (AI) 的医疗设备采用基于标准的方法.
科学领域:
- 医疗器械规则 医疗器械规则
- 医疗保健中的人工智能
- 对比政策分析比较政策分析
背景情况:
- 人工智能 (AI) 的快速发展需要对医疗器械制定不断发展的监管框架.
- 了解全球监管反应对于人工智能驱动的医疗保健创新至关重要.
- 现有的研究往往缺乏直接比较主要监管机构对AI医疗设备的方法.
研究的目的:
- 对美国 (美国),欧盟 (欧盟) 和中国对人工智能医疗设备的监管方法进行比较分析.
- 确定这些主要监管机构如何管理AI医疗设备的关键差异和相似之处.
- 为全球人工智能医疗器械监管现状提供见解.
主要方法:
- 美国,欧盟和中国监管框架的比较政策分析.
- 对政府数据库和监管指导文件的文献审查.
- 获批的人工智能医疗设备的数据提取,重点是中国政府数据库.
主要成果:
- 截至2023年7月,中国已经批准了59种人工智能医疗设备,采用主要基于规则的监管方法.
- 美国和欧盟对支持人工智能的医疗设备采用了更多面向标准的监管策略.
- 在这三个关键全球市场采用的监管理念中存在显著的分歧.
结论:
- 美国和欧盟的以标准为导向的方法可以通过灵活性来促进创新,而中国的基于规则的系统提供了清晰和可预测性.
- 对人工智能医疗设备的监管方法的协调仍然是一个重大挑战.
- 未来的研究应该探索这些不同的监管策略对设备开发和患者访问的影响.
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