作为医疗器械的人工智能监管数据库的当前挑战和前进道路
Ariel Yuhan Ong1,2,3,4, Aditya U Kale5,6,7, Joe Antoun8
1Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom. ariel.ong@nhs.net.
NPJ digital medicine
|February 11, 2026
概括
确保安全的人工智能作为医疗器械 (AIaMD) 需要有效的监管监督. 提高监管数据库中的数据质量和可访问性对于加速创新和患者安全至关重要.
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:
- 有效的监管监督对于AIaMD的安全临床实施至关重要.
- 国际监管数据库是AIaMD评估的关键信息来源.
- 多学科专业知识对于应对AIaMD监管挑战至关重要.
研究的目的:
- 为AIaMD监管监管中的挑战和举措提供见解.
- 突出监管数据库中数据质量和可用性的关键问题.
- 为AIaMDs提出下一代监管数据生态系统的考虑.
主要方法:
- 对国际监管数据库的分析.
- 专家审查和多学科的见解.
- 识别AIaMD监管中的关键挑战和新兴举措.
主要成果:
- 确定了AIaMD监管中的四个关键挑战.
- 讨论了试图规避监管限制的尝试.
- 强调了监管数据库中输入数据质量和可用性的持续问题.
结论:
- 需要提高监管数据的可访问性和透明度.
- 需要为AIaMDs提供下一代监管数据生态系统.
- 全球利益相关者对齐对于制定安全AIaMD创新和改善患者治疗结果的路线图至关重要.
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