美国对支持人工智能的设备的监管环境
Nathan L Liang1, Timothy K Chung2, David A Vorp2
1Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Heart and Vascular Institute, 200 Lothrop Sreet, 3(rd) Floor, Pittsburgh, PA, 15213.
Seminars in vascular surgery
|October 20, 2023
概括
美国的监管环境落后于人工智能 (AI) 设备开发,特别是在放射学和心血管领域. 对于AI设备挑战和临床责任,需要更新美国食品和药物管理局 (FDA) 的指导.
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
- 医疗信息学 医疗信息学
背景情况:
- 支持人工智能 (AI) 的医疗设备市场正在迅速扩大.
- 目前的美国食品和药物管理局 (FDA) 监管途径,如豁免或510k) 预售通知,用于AI设备清除.
- 大多数被清除的AI设备是在放射学和心血管专业领域.
研究的目的:
- 要突出人工智能设备的快速发展与当前美国监管框架之间的差距.
- 识别人工智能设备带来的独特挑战,需要特别的监管关注.
- 强调需要在医疗实践中对人工智能的未来监管指导.
主要方法:
- 对美国人工智能医疗器械的当前监管环境的分析.
- 对这些设备现有的美国食品和药物管理局 (FDA) 清除途径 (豁免和510k) 的审查.
- 确定包括人工智能开发,模型可理解性和持续学习在内的关键挑战.
主要成果:
- 美国的监管环境并没有跟上人工智能设备的快速增长.
- 现有的FDA指南没有充分解决AI设备的独特挑战.
- 与人工智能设备临床使用相关的责任问题仍未得到解决.
结论:
- 迫切需要更新美国食品和药物管理局 (FDA) 的指导,以解决人工智能医疗设备的复杂性.
- 未来的监管框架必须考虑AI特定的挑战,如持续学习和临床实施.
- 解决责任对于将人工智能设备负责任地整合到临床实践中至关重要.
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