Approved trends and product characteristics of digital therapeutics in four countries

作     者：Liang, Jun Fang, Qichuan Jiao, Xiaoyi Xiang, Peng Ma, Junhao Zhang, Zijiao Liu, Yongcheng He, Yunfan Li, Yingjun He, Zhixu Lei, Jianbo 

作者机构：Zhejiang Univ Affiliated Hosp 2 Sch Med Dept AI & IT Hangzhou Peoples R China Zhejiang Chinese Med Univ Sch Med Technol & Informat Engn Hangzhou Peoples R China Zhejiang Univ Ctr Hlth Policy Studies Sch Publ Hlth Hangzhou Peoples R China Zhejiang Univ Affiliated Hosp 2 Natl Key Lab Transvasc Implantable Devices Sch Med Hangzhou Peoples R China Zhejiang Univ Intelligent Med Res Ctr Inst Comp Innovat Technol Hangzhou Peoples R China Digital Therapeut Alliance Asian Sect Hangzhou Peoples R China Hangzhou Med Coll Sch Publ Hlth Dept Epidemiol & Hlth Stat Hangzhou Peoples R China Southwest Med Univ Sch Publ Hlth Luzhou Peoples R China NetEase ThunderFire UX User Experience Ctr Netease Grp Hangzhou Peoples R China Fudan Univ Sch Int Relat & Publ Affairs Shanghai Peoples R China Guizhou Med Univ Ctr Tissue Engn & Stem Cell Res Guiyang Peoples R China Guizhou Med Univ Affiliated Hosp Dept Pediat Hematol Guiyang Peoples R China Southwest Med Univ Affiliated Hosp Clin Res Ctr Luzhou Peoples R China Southwest Med Univ Sch Med Informat & Engn Luzhou Peoples R China Peking Univ Inst Adv Clin Med Ctr Med Informat Beijing Peoples R China 

出 版 物：《NPJ DIGITAL MEDICINE》 (npj Digit. Med.)

年 卷 期：2025年第8卷第1期

页      面：1-13页

核心收录：

基　　金：Zhejiang Provincial Natural Science Foundation of China Municipal Natural Science Foundation of Beijing National TCM innovation team and talent support projects [ZYYCXTD-C-202210] Key Research and Development Program of Zhejiang Province [2024C03215] Hainan Province Science and Technology special fund [ZDYF2022SHFZ292] Hainan Province Clinical Medical Center [QWYH2022341] LY22H180001 

主　　题：Diseases 

摘      要：Digital therapeutics (DTx) provide innovative treatment options. In this study, we identified and compared approved DTx in China, the US, Germany, and Belgium. In total, 507 DTx applications were identified (US, 192;China, 235;Germany, 55;Belgium, 25). China has approved the most, whereas the US initiated approval as early as 2017. In China, most DTx applications focus on disease treatment (88.09%), particularly for neurological (45.96%) and ophthalmic (21.28%) diseases. The US and Belgium emphasize disease management (US: 52.60%, Belgium: 72.00%), whereas Germany focuses on the treatment of mental and behavioral disorders (47.27%). Regarding therapeutic approaches, China s DTx predominantly utilizes computerized cognitive correction (26.38%), whereas the US and Belgium primarily rely on health status monitoring (US, 44.27%;Belgium, 80.00%). Germany s DTx primarily employs cognitive behavioral therapy (69.09%). An online database was established to ensure ease of access. Future studies should focus on generating further evidence to support the broader adoption of DTx.