人工智能医疗软件的监管现状及启示

Chinese Journal of Medical Library and Information Science(2020)

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Abstract
近年来人工智能医疗软件的监管引起了广泛关注,各国、地区和相关组织机构对人工智能医疗软件的监管内容及监管方式各有侧重.对美国FDA、IMDRF等机构的人工智能医疗软件的监管内容及具体方式进行了分析总结,并结合我国当前监管研究现状,提出了我国人工智能医疗软件监管和完善我国人工智能医疗软件监管体系的建议.
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