摘要
随着智能手机的广泛使用,移动医疗类的应用软件的使用也越来越广。国内对于医疗类应用的监管还处于酝酿之中。如何有效地对此类软件进行监管,控制其对患者风险是亟需解决的问题。该文分析了国内外对此类软件监管的现状,归纳国内移动医疗应用软件出现的一些问题,提出一些建议供相关部门参考。
With the widespread use of smart phones, mobile medical class of applications use more widely. The regulation for medical applications is in the offing in domestic. How to effectively regulate such software to control its risks for patients is needed to solve. In this paper, the status of suchsimple software monitoring in domestic and abroad is analyzed, some problems of domestic mobile medical applications are summarized and some recommendations are proposed for the relevant departments.
出处
《中国医疗器械杂志》
CAS
2015年第5期353-355,共3页
Chinese Journal of Medical Instrumentation
基金
辽宁省自然科学基金(201102289)
沈阳市科技专项资金(F12-193-9-12)
关键词
医疗器械
软件监管
FDA
APP
FDA
APP
medical device software supervision
