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Publications

Journal Article Epublish

PubMed: 40419648 DOI: 10.1038/s41746-025-01660-9

Approved trends and product characteristics of digital therapeutics in four countries.

NPJ Digit Med 8(1):308

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

Affiliations

  • Department of AI and IT, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. School of Medical Technology and Information Engineering, Zhejiang Chinese Medical University, Hangzhou, China. Center for Health Policy Studies, School of Public Health, Zhejiang University, Hangzhou, China. National Key Laboratory of Transvascular Implantable Devices, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
  • School of Medical Technology and Information Engineering, Zhejiang Chinese Medical University, Hangzhou, China.
  • Center for Health Policy Studies, School of Public Health, Zhejiang University, Hangzhou, China.
  • Department of AI and IT, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. Intelligent Medical Research Center, Zhejiang University Institute of Computer Innovation Technology, Hangzhou, China. Asian Section, Digital Therapeutics Alliance, Hangzhou, China.
  • Department of Epidemiology and Health Statistics, School of Public Health, Hangzhou Medical College, Hangzhou, China.
  • School of Public Health, Southwest Medical University, Luzhou, China.
  • NetEase ThunderFire UX User Experience Center, Netease Group, Hangzhou, China.
  • School of International Relations and Public Affairs, Fudan University, Shanghai, China.
  • Center of Tissue Engineering and Stem Cell Research, Guizhou Medical University; Department of Pediatric Hematology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
  • Clinical Research Center, Affiliated Hospital of Southwest Medical University, Luzhou, China. School of Medical Information and Engineering, Southwest Medical University, Luzhou, China. Center for Medical Informatics, Institute of Advanced Clinical Medicine, Peking University, Beijing, China.

Abstract

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.

MeSH

Therapeutics, Digital Therapeutics