Liang Jun, Fang Qichuan, Jiao Xiaoyi, Xiang Peng, Ma Junhao, Zhang Zijiao, Liu Yongcheng, He Yunfan, Li Yingjun, He Zhixu, Lei Jianbo
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.
NPJ Digit Med. 2025 May 26;8(1):308. doi: 10.1038/s41746-025-01660-9.
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.
数字疗法（DTx）提供了创新的治疗选择。在本研究中，我们识别并比较了中国、美国、德国和比利时已获批的数字疗法。总共识别出507个数字疗法应用（美国192个；中国235个；德国55个；比利时25个）。中国获批的数字疗法最多，而美国早在2017年就开始批准。在中国，大多数数字疗法应用专注于疾病治疗（88.09%），尤其是神经系统疾病（45.96%）和眼科疾病（21.28%）。美国和比利时强调疾病管理（美国：52.60%，比利时：72.00%），而德国则专注于精神和行为障碍的治疗（47.27%）。在治疗方法方面，中国的数字疗法主要采用计算机化认知矫正（26.38%），而美国和比利时主要依赖健康状况监测（美国，44.27%；比利时，80.00%）。德国的数字疗法主要采用认知行为疗法（69.09%）。建立了一个在线数据库以确保易于访问。未来的研究应专注于生成更多证据以支持数字疗法的更广泛应用。
