Divergent Regulatory and Reimbursement Pathways for Digital Therapeutics: A Scoping Review With Implications for Korea.

Abstract

IntroductionDigital therapeutics (DTx) represent an emerging class of software-based medical devices delivering evidence-based therapeutic interventions. Several countries have developed regulatory and reimbursement frameworks for DTx, while Korea's evaluation system remains in its early stages. This scoping review compared regulatory and reimbursement frameworks for DTx across the United States, Germany, the United Kingdom, and Korea, and separately derived author-led policy implications for a Korean DTx evaluation framework.MethodsFollowing the Arksey and O'Malley framework and PRISMA-ScR guidelines, we searched 11 databases for literature published between January 2015 and December 2025 (final search: 15 February 2026). DTx was operationalized using the Digital Therapeutics Alliance anchor definition with jurisdiction-specific application rules. Data were synthesized along five analytical dimensions: regulation, evidence assessment, reimbursement, postmarket evidence, and governance linkage.ResultsOf 2,847 records, 42 sources (19 articles, 23 policy documents) were included. Jurisdictions diverged most clearly on statutory codification of DTx, the existence of a dedicated reimbursement pathway, and regulator-payer integration. Germany's DiGA Fast-Track had 61 products listed cumulatively (50 active, 11 removed), exceeding one million prescriptions and €234 million expenditure (GKV-SV reporting period through 31 December 2024). Korea provisionally listed four DTx products since 2023.ConclusionsGermany's DiGA system shares more institutional features with Korea's evolving system than do the US or UK frameworks. We propose, as an author-derived synthesis informed by the review, a five-phase Korean DTx framework, while acknowledging substantive system-level differences (payer pluralism, pricing, benefit design, HTA procedure) that constrain direct transferability.