从长椅到床边:通过"真正的生命周期方法"来管理医疗保健人工智能 (AI)
1Affiliate, HMS Center for Bioethics.
American journal of law & medicine
|February 17, 2026
概括
这篇论文提出了一个真正的生命周期方法 (TLA) 规范人工智能 (AI) 在医疗保健. 它强调患者安全和适应性治理,跨越AI开发,批准和部署阶段.
科学领域:
- 医疗保健条例 医疗保健条例
- 人工智能治理管理 人工智能治理
- 医疗器械的合规性 医疗器械的合规性
背景情况:
- 医疗保健中人工智能的现有法律结构是不充分和不一致的.
- 现有的框架未能解决AI在其整个生命周期中的复杂性.
- 需要一个全面的监管方法,专注于患者安全.
研究的目的:
- 为监管医疗保健中的人工智能 (AI) 提出一个真实生命周期方法 (TLA).
- 将TLA框架扩展为管理医疗保健AI的实际见解.
- 用卡塔尔,沙特阿拉伯和阿联的例子提供全球实施的模型.
主要方法:
- 对人工智能生命周期阶段的分析:研发,批准和部署.
- 审查现有的医疗器械框架及其对AI的适用性.
- 检查来自卡塔尔,沙特阿拉伯和阿联的开创性监管例子.
主要成果:
- 在医疗保健的AI生命周期中确定了治理差距.
- 强调需要在研发领域制定强有力的指导方针和认证.
- 强调需要针对人工智能批准和部署制定量身定制的规定.
结论:
- 现有的法律结构对于医疗保健中全面的AI监管是不足的.
- 一种更广泛的监管方法,专注于整个AI生命周期的患者安全是必不可少的.
- 该TLA为全球管理医疗保健AI提供了实际框架.
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