人工智能医疗器械对临床决策支持的评估和监管
1Palliative and Advanced Illness Research Center; Pulmonary, Allergy, and Critical Care Division, Department of Medicine; Division of Informatics, Department of Biostatistics, Epidemiology & Informatics; Leonard Davis Institute of Health Economics; Penn Institute for Biomedical Informatics; AI2D Center for AI and Data Science for Integrated Diagnostics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA;
Annual review of biomedical data science
|February 19, 2025
概括
人工智能 (AI) 医疗设备有望改善医疗保健,但缺乏有效性,安全性和公平性的证据. 需要进一步的研究和公开讨论来指导其监管,并确保患者受益.
科学领域:
- 医疗技术 医疗技术 医学技术
- 医疗信息学 医疗信息学
- 监管科学 监管科学
背景情况:
- 几十年前开发的人工智能 (AI) 方法在临床环境中越来越多地显示出潜力.
- 人工智能系统可以解释,预测和生成医疗信息,从而影响患者的护理.
- 人工智能医疗设备与传统设备有相似之处和差异.
研究的目的:
- 审查当前的证据和对AI医疗设备的监管和评估的努力.
- 强调需要评估人工智能医疗器械的有效性,安全性和公平性.
- 为公众讨论提供信息,并指导医疗保健中人工智能的监管框架.
主要方法:
- 对人工智能医疗器械监管和评估的最新进展和证据的文献综述.
- 对有关人工智能医疗器械有效性,安全性和公平性的现有证据状况的分析.
- 识别有关AI医疗器械风险和益处的利益相关者的观点.
主要成果:
- 尽管有热情,但实际上对人工智能医疗设备的有效性有有限的经验证据.
- 关于人工智能医疗设备的安全性和公平性的知识仍然很少.
- 不同的利益相关者观点需要知情的公共话语.
结论:
- 人工智能医疗设备提供了重大机遇,但需要严格的评估.
- 确保人工智能医疗器械的有效性,安全性和公平性对于成功融入医疗保健至关重要.
- 持续的研究和监管适应对于负责任地利用人工智能的潜力至关重要.
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