中国医疗设备2017，Vol.32Issue(6)：12-15,4.DOI:10.3969/j.issn.1674-1633.2017.06.004
移动医疗器械APP软件监管技术探讨
Study on the Regulation of Mobile Medical Devices APP Software
摘要
Abstract
With the rapid development of internet technology, new technologies and new methods, such as internet technology, mobile internet, big data and cloud computing and so on, are rapidly developed and widely applied in medical equipment industry. The emergence of mobile medical devices APP software is making revolutionary changes to the traditional healthcare from the aspects of diagnosis, monitoring, and treatment. An intelligent medical era is approaching. Along with the emergence of new medical products, how to effectively control its safety and effectiveness raised new challenges to regulatory agencies. Based on the definition and features of mobile medical APP software, this paper combined the regulation ideas and methods of the United States, the European Union and China, and performed an in-depth analysis on the challenge of software update regulation, and proposed regulatory advice and faced the challenge for the mobile medical APP software, expected to provide support and help for the regulation work.关键词
APP软件/医院信息系统/移动医疗器械/软件更新/移动互联设备Key words
APP software/hospital information system/mobile medical instrument/software update/mobile internet device分类
信息技术与安全科学引用本文复制引用
王晨希,李澍,王浩,罗维娜,任海萍..移动医疗器械APP软件监管技术探讨[J].中国医疗设备,2017,32(6):12-15,4.基金项目
中国食品药品检定研究院中青年基金项目(2015C02) （2015C02）
中国药品监督管理研究会课题"移动医疗发展趋势与监管政策研究". （）
