Digital Therapeutics Regulation Strategies of Ten Different Countries: Scoping Review and Policy Mapping

Background: Digital Therapeutics (DTx), defined as software-driven interventions requiring clinician prescription are innovative solutions that use meaningful data to provide personalized, evidence-based treatments for various medical conditions. Robust evaluation and regulation mechanisms are vital in facilitating the access of DTx. However, challenges remain in clinical trial standardization, regulatory approval, product development, and reimbursement models. Comprehensive assessments of global DTx governance frameworks remain understudied and inadequately characterized; existing research has primarily focused on the regulatory innovations in a certain country. Objective: This study systematically reviews and analyzes the available digital therapeutics regulation strategies in 10 different countries (America, German, Korea, Japan, China, US, France, Australia, Singapore, Switzerland), focusing on regulatory frameworks, Health Technology Assessment (HTA), 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 study uses a policy mapping framework to collect information on current DTx review and regulation practices across multiple layers of governance. Articles addressing the approval, regulation and reimbursement of DTx in America, German, Korea, Japan, China, US, France, Australia, Singapore, Switzerland are searched in four databases: MEDLINE, Embase, PubMed, and Web of Science. Additionally, relevant laws, regulations, departmental rules, and guidelines of DTx definition and market access process on the official websites of government departments and their technical institutions are searched. Individual country information is tabulated and the disparities between countries are narratively synthesized. Results: Our search strategy yielded a total of 3028 records, of which 60 were ultimately included in this study. All countries have system-wide strategic programs to advance digital aspects of healthcare. Out of the examined countries/regions, the focus of Germany comes closest to DTx in its definitions and criteria. Germany is the first country to create the fast-track process and assessment criteria for the reimbursement of prescription DTx by passing the Digitale-Versorgung-Gesetz in 2019. Globally, DTx regulatory frameworks exhibit significant regional disparities, characterized by methodological inconsistencies, a lack of unified frameworks, and opaque approval processes, all of which hinder global regulatory harmonization. For AI-embedded DTx, the FDA’s Predetermined Change Control Plan (PCCP) and the EU Medical Device Regulation’s (MDR) dynamic certification mechanisms address algorithmic adaptability challenges, while the UK’s NICE advances Bayesian HTA models to shift evidence generation from randomized controlled trials (RCT) toward continuous real-world validation. Post-market surveillance systems remain underdeveloped, with data security risks—including multimodal sensitive data leakage (e.g., PGHD, EHR, biometrics) and cross-platform re-identification vulnerabilities—necessitating the integration of technologies such as differential privacy and blockchain, alongside harmonization of conflicting requirements under GDPR, HIPAA, and CCPA. Conclusion: Challenges lie in regulatory paradigm transition, global governance coordination, and value-based evaluation. Key priorities for future development include shifting from product-centric approval to value-based assessment, optimizing privacy-utility trade-offs, advancing federated learning validation, and implementing AI-driven regulatory updates.