数字健康技术评估与应用的国际经验  

International experience in the evaluation and application of digital health technology

作　　者：邢倩 何达[1] 符雨嫣 罗雅双 汪茹 王海银[1] 金春林[1] XING Qian;HE Da;FU Yuyan;LUO Yashuang;WANG Ru;WANG Haiying;JIN Chunlin(Shanghai Health Development Research Center/Shanghai Medical Information Center,Shanghai 200031,China)

机构地区：[1]上海市卫生和健康发展研究中心(上海市医学科学技术情报研究所),上海200031

出　　处：《健康发展与政策研究》2024年第1期29-35,共7页HEALTH DEVELOPMENT AND POLICY RESEARCH

摘　　要：作为新一代的卫生技术,数字健康技术(digital health technology,DHT)在疾病预防、诊断、治疗和健康管理等诊疗全流程中得到了广泛认知和应用,由于其具有不同于药品、医疗器械等传统卫生技术的特殊属性,因此在产品注册认证、上市监管、医疗保险准入等环节出现了新的挑战,需要进行科学、全面的评估,国内尚未明确DHT评估标准和应用指导。本文介绍DHT的国际评估经验,并比较英国、德国、芬兰和韩国DHT的分类方式、证据标准、评估方法和医疗保险支付手段,以期为我国DHT的监管和发展提供参考依据。As a new generation of health technology,digital health technology(DHT)has been widely recognised and applied in the whole process of disease control and prevention,diagnosis,treatment,and health management.Special attributes unique from traditional health technologies such as pharmaceuticals and medical devices have introduced new challenges in aspects including product registration and certification,listing supervision,and health insurance access,necessitating a thorough and scientific evaluation.There are no clear DHT evaluation standards and application guidelines in China.The study explores the international experience of DHTs practices in the United Kingdom,Germany,Finland and Republic of Korea.It compares the classification,evidence standards,assessment methods and health insurance payment methods of DHTs in these developed countries to offer insights for regulating and developing DHTs in China.

关 键 词：数字健康技术 卫生技术评估 应用 国际经验 

分 类 号：R199[医药卫生—卫生事业管理]