Regulatory Frameworks and Reimbursement Pathways for Digital Therapeutics Medical Devices: A Comparative Policy Analysis of South Korea, Germany, France, and Japan

다국어 초록 (Multilingual Abstract)

Objective: This study aimed to identify structural differences in policy frameworks for digital therapeutics medical devices (DTx) and to derive policy implications for improving patient access in South Korea through cross-national comparison. Methods: A comparative analysis was conducted across three dimensions: regulatory definition and scope, market authorization pathways, and reimbursement mechanisms in South Korea, Germany, France, and Japan. Data were collected from official documents, policy reports, and peer-reviewed literature, and synthesized using comparative tables and narrative analysis. Results: All four countries regulate DTx within medical device frameworks but differ in the clarity of definitions and authorization structures. Germany has established a distinct framework through digital health applications, whereas other countries, including South Korea, rely on broader software as a medical device classifications. Greater variation was observed in reimbursement pathways. Germany provides a structured mechanism linking authorization to statutory health insurance coverage, while South Korea lacks a dedicated pathway and relies on prolonged provisional arrangements with high patient cost-sharing. France and Japan represent intermediate models. These differences are reflected in utilization, with cumulative prescriptions exceeding one million in Germany, approximately 200,000 in Japan, and only 31 in South Korea in the first half of 2024. Conclusion: An authorization–reimbursement disconnect persists in South Korea, limiting patient access despite regulatory approval. Aligning reimbursement with authorization through structured pathways may improve access and support evidence generation.