以人工智能为基础的软件作为医疗设备 (AI-SaMD):系统审查
Shouki A Ebad1, Asma Alhashmi2, Marwa Amara2
1Center for Scientific Research and Entrepreneurship, Northern Border University, Arar 73213, Saudi Arabia.
Healthcare (Basel, Switzerland)
|April 12, 2025
概括
基于人工智能的软件作为医疗设备 (AI-SaMD) 的研究是有限的. 这次审查确定了挑战,并强调了AI-SaMD的实践和实验研究.
科学领域:
- 医疗技术 医疗技术 医学技术
- 人工智能的人工智能
- 医疗保健信息学 医疗保健信息学
背景情况:
- 以人工智能为基础的软件作为医疗器械 (AI-SaMD) 是一个不断增长的领域,监管部门的批准越来越多.
- 跨越技术,医疗保健和国家安全的AI-SaMD研究仍然有限.
- 关于AI-SaMD的技术,临床和监管方面的知识差距存在.
研究的目的:
- 系统地审查过去十年 (2015-2024) 的AI-SaMD文献.
- 将关键发现分类,确定关键挑战,并对AI-SaMD.综合洞察力.
- 通过分析技术,临床和监管层面来弥合研究差距.
主要方法:
- 系统的文献审查,遵循PRISMA框架.
- 2015年至2024年间发表的AI-SaMD研究的选择.
- 分析出版场所,地理趋势,挑战和研究缺口.
主要成果:
- AI-SaMD的研究主要集中在放射学和眼科等专业领域,而不是一般实践.
- 关键的实施挑战包括监管框架,人工智能不当行为 (可解释性,监督) 和数据治理 (隐私,共享).
- 有效的AI-SaMD实施需要解决监管问题,促进跨学科合作,临床医师培训,电子健康记录集成和严格的模型验证.
结论:
- 该研究为利益相关者提供了洞察力,倡导实践,实验研究而不是理论分析.
- 优先考虑现实世界的应用需要超越理论讨论.
- 概述了未来的研究方向,强调了当前理论方法的局限性.
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