国内外数字疗法产品监管政策与产品应用进展  

Domestic and International Regulatory Policies and Application Progress of Digital Therapeutics

作　　者：徐东紫 严舒[1] 张婷[1] 陈娟[1] 欧阳昭连[1] XU Dongzi;YAN Shu;ZHANG Ting;CHEN Juan;OUYANG Zhaolian(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China)

机构地区：[1]中国医学科学院医学信息研究所,北京100020

出　　处：《中国医疗设备》2024年第10期28-33,共6页China Medical Devices

基　　金：中国医学科学院医学与健康科技创新工程(2021-I2M-1-056);国家自然科学基金(L1924064);深圳市“医疗卫生三名工程”(SZSM202311031)。

摘　　要：随着数字技术的不断发展,数字疗法作为一种新兴的医疗手段已经成功应用于精神疾病与部分慢性疾病的管理与防治中。近年来,国内外对数字疗法产品的监管和上市审批开展了研究探索,目前全球数字医疗产品基本按照医疗器械软件进行监管和审批上市。本文先厘清了数字疗法的定义、产品属性与要素,根据数字疗法结合医疗器械和人工智能的特点,梳理总结美国、德国和中国对数字疗法产品的监管政策和产品审评审批上市的通道,调研总结了国内外数字疗法产品上市情况,分析总结了上市产品特点,以期为我国数字疗法产品的监管提供信息支撑。With the continuous advancement of digital technology,digital therapeutics has emerged as a new medical approach,successfully applied in the management and prevention of mental health disorders and certain chronic diseases.In recent years,research and exploration have been carried out on the regulation and listing approval of digital therapy products at home and abroad,and at present,global digital medical products are basically regulated and approved for listing in accordance with medical device software.This paper clarified the definition of digital therapy,product attributes and elements,and according to the characteristics of digital therapy combined with medical devices and artificial intelligence,sorted out and summarized the regulatory policies of digital therapy products in the United States,Germany and China and the channels for product review and approval for listing,investigated and summarized the listing situation of digital therapy products at home and abroad,and analyzed and summarized the characteristics of listed products,in order to provide information support for the supervision of digital therapy products in China.

关 键 词：数字疗法 医疗器械软件 全生命周期 注册审批 区块链 元宇宙 

分 类 号：R459.9[医药卫生—治疗学] R19[医药卫生—临床医学]