摘要
新兴技术的发展,推动数字疗法逐渐流行,软件已成为医疗产品的重要组成部分。根据国际医疗器械监管机构论坛的定义,SaMD(software as a medical device)是指“具有一个或多个医疗用途,且无需医疗器械硬件即可完成预期用途的软件”,但由于国内外尚无对其完整全面的评估与监管体系,其监管问题亟须加强监管研究。本文通过介绍SaMD相关概念及政策、人工智能背景下SaMD面临的监管挑战、我国和WHO对数字医疗的管理原则等情况,使读者获悉为加强SaMD审评与监管的思路,以期对完善我国SaMD监管原则提供启示。
The development of emerging technologies has promoted the popularity of digital therapy,and software has become an important part of medical products.The International Medical Device Regulators Forum(IMDRF)defines′software as a medical device(SaMD)′as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.However,due to the lack of a complete and comprehensive evaluation and supervision system at home and abroad,it is urgent to strengthen supervision research on its supervision.This paper introduced the related concepts and policies of SaMD,the regulatory challenges faced by SaMD under the background of artificial intelligence,and the management principles of digital medical care in China and WHO,so as to inform readers of the ideas for strengthening the review and supervision of SaMD,with a view to providing enlightenment for improving the regulatory principles of SaMD in China.
作者
王颖
WANG Ying(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai 200040,China)
出处
《药学研究》
CAS
2024年第4期359-365,395,共8页
Journal of Pharmaceutical Research
关键词
数字健康
监管框架
监管原则
医疗器械
独立软件
Digital health
Regulatory framework
Regulatory principles
Software as a medical device
