摘要
随着移动智能手机的广泛应用,医疗健康领域中移动应用程序(APP)产品日益增多。参考美国食品药品监督管理局(FDA)对移动APP产品的监管,根据我国对医疗器械的定义,移动APP产品可以分为移动健康APP(非医疗器械产品)和移动医疗APP(医疗器械产品)。阐述移动APP在医疗健康领域的应用现状,从监管科学的角度分析移动APP在医疗器械应用中需考虑的安全性风险,探索建立适合移动医疗APP特点的评价体系,为企业和监管部门提供该类产品安全有效性的评价方法,推动其在医疗卫生领域的规范化发展。
With the wide application of mobile smart phones,there are more and more mobile APPs products in the field of medical treatment and health.The mobile APP products can be divided into mobile health APP(non-medical device product)and mobile medical APP(medical device product)by referring to the regulation of American food and drug administration(FDA)on mobile app products,and by according to the definition of medical device in China.This paper stated the current application situation of mobile APP in the field of medical health,and analyzed safety risk,which should be considered in the application of medical device,of mobile APP from the aspect of supervision science,and explored how to establish an evaluation system that suited to the characteristics of mobile medical APP.And this paper can provide safe and effective evaluation method of this kind of product for enterprise and supervision department,and promote standardized development of them in the field of medical health.
作者
宓云軿
孙轶康
钱虹
MI Yun-ping;SUN Yi-kang;QIAN Hong(Department of Medical Device Registration,Shanghai Center for Medical Device&Cosmetic Evaluation and Inspection,Shanghai 200020,China;不详)
出处
《中国医学装备》
2021年第2期162-165,共4页
China Medical Equipment
基金
国家重点研发计划(2018YFC2000800)“主动健康数据采集产品的安全性和有效性评价规范研究”。
