随着智能手机的普及和手机应用软件(APP)的快速开发应用，移动医疗APP逐渐出现并快速发展，成为个人健康管理的重要手段之一，但同时医疗健康类软件不良事件也日益增多，对用户健康构成威胁，移动医疗APP的监管问题也开始引起各国重视。本研究以医疗器械的监管方法为参考，基于风险管理理论并结合我国移动医疗APP的特点和发展现状，有针对性地提出移动医疗APP的分阶段、分类监管设想，以保证用户安全和健康，促进行业的有序发展。%With the popularity of smart phone and the rapid development of mobile software, mobile medical applica-tions (APP) are being rapidly developed, which become one of the important means of personal health management. However, the adverse events of mobile medical APP are increasing at the same time, threatening to users' health. Thus, the regulation of mobile medical application is starting to attract the attention of worldwide governments. With the ref-erence of the mature supervision experience in medical device field, this paper gives a blueprint of staged and classi-fied supervision of mobile medical APP based on risk management theory as well as considering the features and cur-rent situations of mobile medical APP development, which is hoped to ensure APP user's safe and health and is to pro-mote the optimum development of the industry.
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