Earticle

초록

영어

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.

목차

ABSTRACT
Introduction
Materials and Methods
Study Design
Analytical Framework
Data Source and Search Strategy
Results
Definition and Market Authorization of Digital Therapeutics Medical Devices
Fast-track Pathways for Digital Therapeutics Medical Devices
Reimbursement Pathways and Coverage of Digital TherapeuticsMedical Devices
Case-based Utilization of Digital Therapeutics Medical Devices
Discussion
The findings of this study have several implications for the development of DTx policy in South Korea.
Conclusion
Acknowledgment(s)
Conflict of Interest
References

키워드

저자

• Chae Yun Kim [ College of Pharmacy, Chung-Ang University ]
• Hyun Ji Kim [ College of Pharmacy, Chung-Ang University ]
• Jun Yeong Kim [ College of Pharmacy, Chung-Ang University ]
• Jeong Kwon Ryu [ College of Pharmacy, Chung-Ang University ]
• Hyo Min Yu [ College of Pharmacy, Chung-Ang University ]
• Seung Jae Lee [ College of Pharmacy, Chung-Ang University ]
• Seong Keun Cho [ College of Pharmacy, Chung-Ang University ]
• Yu Kyung Song [ College of Pharmacy, Chung-Ang University ]
• Yun Jae Jung [ College of Pharmacy, Chung-Ang University ]
• Min Ji Kim [ College of Pharmacy, Chung-Ang University ]
• Jong Hyuk Lee [ College of Pharmacy, Chung-Ang University ] Corresponding Author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615