图像中的人工智能:监管格局
1UCL, Gower Street, London, WC1E 6BT, United Kingdom.
The British journal of radiology
|February 17, 2024
概括
医学成像中的人工智能 (AI) 正在快速发展,但许多研究缺乏严谨性. 新的法规要求人工智能医疗设备的更强有力的开发和验证,以确保患者的安全和信任.
科学领域:
- 医疗成像医学成像
- 人工智能的人工智能
- 监管科学 监管科学
背景情况:
- 近年来,医疗成像中的人工智能 (AI) 应用大幅增长.
- 尽管取得了进展,但AI医学成像文献中的很大一部分表现出方法上的弱点.
- 现有的AI工具往往缺乏临床整合所需的严格验证.
研究的目的:
- 突出越来越多的人工智能医疗设备和出版物.
- 解决当前AI医学成像文献中发现的弱点.
- 讨论不断变化的监管要求对AI医疗器械开发和验证的影响.
主要方法:
- 在医学成像文献中对人工智能的系统审查.
- 对支持人工智能的医疗设备不断变化的监管指南的分析.
- 讨论风险减轻策略,包括偏差识别和临床验证.
主要成果:
- 人工智能医学成像出版物和设备的显著增加.
- 识别现有文献的一部分实质性缺陷.
- 积极主动的监管框架的出现,要求人工智能设备开发的更高标准.
结论:
- 更严格的监管要求,虽然可能延长开发时间,但对于确保人工智能医疗器械的可靠性和临床意义至关重要.
- 解决诸如偏见等风险,并在现实的临床环境中确保验证至关重要.
- 将学术研究与监管框架保持一致,将改善文献质量,并促进人工智能工具转化为临床实践.
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