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. 2025 Aug 1;8(1):495.
doi: 10.1038/s41746-025-01879-6.

Healthcare effects and evidence robustness of reimbursable digital health applications in Germany: a systematic review

Khira Sippli #  1 , Stefanie Deckert #  2 , Jochen Schmitt  2 , Madlen Scheibe  2
Affiliations

Healthcare effects and evidence robustness of reimbursable digital health applications in Germany: a systematic review

Khira Sippli et al. NPJ Digit Med. .

Abstract

In Germany, statutory health insurance reimburses digital health applications (DiGAs) approved by the Federal Institute for Drugs and Medical Devices (BfArM). Permanent approval requires evidence of positive healthcare effects, either medical benefits or patient-relevant improvements in structures and processes (pSVV). This systematic review analyzed all 23 DiGA approval studies available as of March 15, 2024. The studies, conducted between 2012 and 2022, included 56 to 1245 participants and intervention durations from 1.5 to 12 months. Drop-out rates varied (mean 21.7% in intervention, 11.8% in control group). Most studies (13/23) focused on primary outcomes related to mental health conditions; one addressed pSVV. All reported significant medium to large effects, but risk of bias was high, particularly in outcome measurement (21/23) and due to missing data (15/23). These findings raise concerns about the robustness of the evidence supporting DiGA efficacy. The review recommends revising the DiGA approval process to enhance study quality. The systematic review was registered prospectively with PROSPERO https://www.crd.york.ac.uk/prospero/ (CRD42023460497).

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Conflict of interest statement

Competing interests: K.S., M.S. and S.D. declare no competing interests. Unrelated to this study, J.S. reports institutional grants for investigator-initiated research from the German G.B.A., B.M.G., B.M.B.F. and E.U. Federal State of Saxony, Novartis, Sanofi, A.L.K. and Pfizer. He has also participated in advisory board meetings as a paid consultant for Sanofi, Lilly, and A.L.K. J.S. is a member of the Expert Council on Health and Care at the Federal Ministry of Health and a member of the government commission for modern and needs-based hospital care of the current German Coalition.

Figures

Fig. 1
Fig. 1. PRISMA flow chart.
The figure outlines the screening and selection process of DiGA approval studies included in the systematic review, following the PRISMA 2020 guidelines.
Fig. 2
Fig. 2. Results of the RoB2 assessment for 22 randomized parallel-group trials (ordered by DiGA category, then chronologically).
The figure presents the RoB2 judgments for five bias domains and the overall risk of bias for each of the 22 included randomized parallel-group DiGA approval studies. Risk levels are color-coded as follows: green (low risk), yellow (some concerns), red (high risk). Figure 2 shows the studies ordered by DiGA category from the DiGA directory, as in Tables 1 and 2, then according to the chronological appearance of the study.
Fig. 3
Fig. 3. Results of the RoB2 assessment for cluster-randomized parallel-group trials.
The figure presents the RoB2 judgments for five bias domains and the overall risk of bias for the included cluster-randomized parallel-group DiGA approval study. Risk levels are color-coded as follows: green (low risk), yellow (some concerns), red (high risk).
Fig. 4
Fig. 4. Overview of RoB across all included studies and domains.
The figure displays the percentage distribution of RoB2 ratings (low risk, some concerns, high risk) across the five bias domains and overall for all 23 included studies.
See this image and copyright information in PMC

References

    1. Bundesministerium für Gesundheit. Digital-Gesetz (DigiG). BGBl. Teil I Nr. 39, 22.12.2023, S. 4118–4137. (Deutschland, 2023).
    1. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Das Fast-Track-Verfahren für digitale Gesundheitsanwendungen (DiGA) nach § 139e SGB V- DiGA Leitfaden, Version 3.5. (Bundesministerium für Gesundheit, 2023).
    1. Bundesministerium für Gesundheit. Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation (Digitale-Versorgung-Gesetz – DVG, 2019).
    1. Gemeinsamer Bundesausschuss (G-BA). Nutzenbewertung von Arzneimitteln gemäß § 35a SGB V. https://www.g-ba.de/themen/arzneimittel/arzneimittel-richtlinie-anlagen/...
    1. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). DiGA-Verzeichnis. https://diga.bfarm.de/de/verzeichnis (2025).

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