人工智能医疗软件的监管现状及启示  

Supervision of artificial intelligence medical software and its enlightenments

作　　者：刘雅茹 崔春舜 林炜炜 袁子焰 孙晓北[1] 徐畅 付玉伟 高东平[1] LIU Ya-ru;CUI Chun-shun;LIN Wei-wei;YUAN Zi-yan;SUN Xiao-bei;XU Chang;FU Yu-wei;GAO Dong-ping(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China;Qingdao Central Cancer Hospital,Qingdao 266000,Shandong Province,China)

机构地区：[1]中国医学科学院医学信息研究所,北京100020 [2]青岛市中心(肿瘤)医院,山东青岛266000

出　　处：《中华医学图书情报杂志》2020年第10期38-43,共6页Chinese Journal of Medical Library and Information Science

基　　金：2019年度国家社会科学基金重大项目“大数据背景下人工智能及其逻辑的哲学反思”(19ZDA041);中国医学科学院医学与健康科技创新工程“医学大数据采集与分析评估项目”(2016-I2M-2-004)。

摘　　要：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。The supervision of artificial intelligence medical software has led to widespread attention in the world.Different countries,regions,relevant organizations and institutions lay their special emphasis on the supervision contents and methods of artificial intelligence medical software.The supervision contents and methods of artificial intelligence medical software in FDA and IMDRF of USA were summarized and analyzed with suggestions proposed for our country to supervise the artificial intelligence medical software and to improve its supervision system.

关 键 词：人工智能 医疗器械软件 标准化 监管工作 

分 类 号：R-05[医药卫生] TP311[自动化与计算机技术—计算机软件与理论]