Digital Therapeutics in China: Comprehensive Review.

Background: Digital therapeutics (DTx) are software-driven interventions that provide personalized, evidence-based treatments for various medical conditions. China's rapid technological adoption, large population, and supportive government policies position it as a potential global leader in DTx. However, challenges remain in clinical trial standardization, regulatory approval, product development, and reimbursement models. A comprehensive assessment of clinical evidence, commercialization trends, and regulatory frameworks is essential for understanding China's evolving DTx ecosystem and its global implications.

Objective: This study systematically reviews and analyzes the DTx landscape in China, focusing on clinical trials, commercial products, regulatory frameworks, and pricing and reimbursement models. The findings provide insights for countries aiming to develop, regulate, and integrate DTx solutions into health care systems.

Methods: This comprehensive review integrates multiple methodological approaches to examine different aspects of the DTx ecosystem in China. We conducted a systematic review and meta-analysis to evaluate clinical trials, searching PubMed, Google Scholar, IEEE, Web of Science, and ScienceDirect until July 2024. Meta-analyses used random-effects models, reporting results as standardized mean differences (SMDs) and 95% CIs. For commercial products, a scoping review using the National Medical Products Administration database was performed. Regulatory policies were systematically identified through a manual review of official government sources, while pricing and reimbursement models were analyzed through a comprehensive assessment of public and private insurance policies, government initiatives, and commercial pathways.

Results: : A total of 96 clinical trials on DTx in China were identified, with cognitive disorders (n=21, 22%) and diabetes (n=20, 21%) being the most frequently studied, followed by cardiovascular diseases (n=8, 8%), sleeping disorders (n=6, 6%), and smoking cessation (n=6, 6%). Meta-analysis for diabetes DTx showed a trend toward improved hemoglobin A_1c levels in digital intervention groups compared to controls (SMD -0.96, 95% CI -2.03 to 0.11) but did not reach statistical significance (I²=97%). Meta-analysis for cognitive disorder DTx showed significant improvement in global cognitive function in DTx-treated participants (SMD 0.65, 95% CI 0.37-0.94), despite notable heterogeneity (I²=71.7%). The commercial landscape analysis identified 97 active DTx solutions, primarily targeting cognitive impairment (38 companies), ophthalmic diseases (30 companies), and respiratory diseases (5 companies). The regulatory review highlighted China's reliance on general medical device policies under the National Medical Products Administration rather than DTx-specific regulations, with emerging regional innovation policies supporting industry growth. Pricing analysis revealed diverse reimbursement models, including value-based pricing, private insurance partnerships, and government-facilitated programs.

Conclusions: China has made substantial progress in DTx development but still faces challenges in clinical trial standardization, regulatory approval, and reimbursement. Key factors driving DTx adoption include targeted indications, standardized clinical trials, streamlined regulation, and diversified pricing models. China's experience provides valuable lessons for other countries with emerging digital health ecosystems as they develop DTx research, regulations, and integration strategies.

Trial registration: PROSPERO CRD42024615584; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024615584.