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

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Title: Divergent Regulatory and Reimbursement Pathways for Digital Therapeutics: A Scoping Review With Implications for Korea.
Authors: Kim, Mincheol1,2 (AUTHOR), Kim, Gaeun3 (AUTHOR) gaeunkim0325@gmail.com
Source: Inquiry (00469580). 7/7/2026, Vol. 63, p1-11. 11p.
Subject Terms: Health insurance reimbursement laws, Digital technology, Health insurance reimbursement, Digital health, Health policy, Medical equipment laws, Conceptual structures
Geographic Terms: Germany, United States, United Kingdom, South Korea
Abstract: Introduction: Digital 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. Methods: Following 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. Results: Of 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. Conclusions: Germany'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. [ABSTRACT FROM AUTHOR]
Copyright of Inquiry (00469580) is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Divergent Regulatory and Reimbursement Pathways for Digital Therapeutics: A Scoping Review With Implications for Korea.
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  Data: <searchLink fieldCode="AR" term="%22Kim%2C+Mincheol%22">Kim, Mincheol</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kim%2C+Gaeun%22">Kim, Gaeun</searchLink><relatesTo>3</relatesTo> (AUTHOR)<i> gaeunkim0325@gmail.com</i>
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  Data: <searchLink fieldCode="JN" term="%22Inquiry+%2800469580%29%22">Inquiry (00469580)</searchLink>. 7/7/2026, Vol. 63, p1-11. 11p.
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  Data: <searchLink fieldCode="DE" term="%22Health+insurance+reimbursement+laws%22">Health insurance reimbursement laws</searchLink><br /><searchLink fieldCode="DE" term="%22Digital+technology%22">Digital technology</searchLink><br /><searchLink fieldCode="DE" term="%22Health+insurance+reimbursement%22">Health insurance reimbursement</searchLink><br /><searchLink fieldCode="DE" term="%22Digital+health%22">Digital health</searchLink><br /><searchLink fieldCode="DE" term="%22Health+policy%22">Health policy</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+equipment+laws%22">Medical equipment laws</searchLink><br /><searchLink fieldCode="DE" term="%22Conceptual+structures%22">Conceptual structures</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Germany%22">Germany</searchLink><br /><searchLink fieldCode="DE" term="%22United+States%22">United States</searchLink><br /><searchLink fieldCode="DE" term="%22United+Kingdom%22">United Kingdom</searchLink><br /><searchLink fieldCode="DE" term="%22South+Korea%22">South Korea</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Digital 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. Methods: Following 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. Results: Of 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. Conclusions: Germany'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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Inquiry (00469580) is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1177/00469580261467451
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      – Code: eng
        Text: English
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      – SubjectFull: Health insurance reimbursement laws
        Type: general
      – SubjectFull: Digital technology
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      – SubjectFull: Health insurance reimbursement
        Type: general
      – SubjectFull: Digital health
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      – SubjectFull: Health policy
        Type: general
      – SubjectFull: Medical equipment laws
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      – SubjectFull: Conceptual structures
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      – SubjectFull: Germany
        Type: general
      – SubjectFull: United States
        Type: general
      – SubjectFull: United Kingdom
        Type: general
      – SubjectFull: South Korea
        Type: general
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      – TitleFull: Divergent Regulatory and Reimbursement Pathways for Digital Therapeutics: A Scoping Review With Implications for Korea.
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            NameFull: Kim, Mincheol
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            – D: 07
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              Text: 7/7/2026
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              Y: 2026
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