我们是否需要人工智能作为医疗设备的预资格,以推动公平的采用?
Bilal A Mateen1,2, Bernard Aryeetey3, Delese Mimi Darko4,5
1PATH, Seattle, Washington, USA. bmateen@path.org.
NPJ digital medicine
|December 17, 2025
概括
世界卫生组织 世界卫生组织
科学领域:
- 全球健康 全球健康
- 医疗技术 医疗技术 医学技术
- 监管科学 监管科学
背景情况:
- 人工智能 (AI) 为推进全球卫生倡议提供了重大机会.
- 现有的监管框架可能无法充分解决动态人工智能系统带来的独特挑战.
- 人工智能监管中的差异阻碍了全世界对这些变革性技术的公平获取.
研究的目的:
- 评估世界卫生组织预资格 (PQ) 框架在全球卫生中对人工智能 (AI) 的适用性.
- 在应用于AI技术时,识别当前监管范式的局限性.
- 提出一个新的框架,PQ4AI,用于监管医疗保健中的AI.
主要方法:
- 世界卫生组织预资格框架的分析.
- 评估适应动态AI系统的静态产品法规所面临的挑战.
- 开发人工智能预资格 (PQ4AI) 的概念模型.
主要成果:
- 当前以产品为中心的监管模式对于动态的人工智能系统来说是不够的.
- 需要修改框架来适应AI不断变化的性质.
- 拟议的PQ4AI框架旨在将全球标准与当地监管需求相结合.
结论:
- 将世卫组织的PQ框架扩展到AI,需要进行重大调整.
- 一个重新设计的PQ4AI框架可以确保在全球卫生中安全,有效和公平的AI部署.
- 将全球技术保证与当地监管问责制之间的平衡对于人工智能采用至关重要.
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