Evidence map›Paper›PMID 36059268›Full record

ReviewJournal of diabetes science and technology2024

The German Fast Track Toward Reimbursement of Digital Health Applications: Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes.

Freimut Schliess, Tatiana Affini Dicenzo, Nandor Gaus, Jean-Marc Bourez, Constance Stegbauer, Joachim Szecsenyi, Malte Jacobsen, Dirk Müller-Wieland, Bernhard Kulzer, Lutz Heinemann

Abstract readReview
In one paragraph

Review in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Artificial Intelligence Across the Drug Development Lifecycle.Medical sciences (Basel, Switzerland) · 2026
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  8. Quality assessment of mHealth apps: a scoping review.Frontiers in health services · 2024
    Article
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  10. Review
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  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Freimut SchliessProfil Institut für Stoffwechselforschung GmbH, Neuss, Germany.ORCID 0000-0002-8232-9971
Tatiana Affini DicenzoProfil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
Nandor GausEIT Health e.V., Munich, Germany.
Jean-Marc BourezEIT Health e.V., Munich, Germany.
Constance StegbauerAQUA Institute for Applied Quality Improvement and Research in Healthcare GmbH, Göttingen, Germany.
Joachim SzecsenyiAQUA Institute for Applied Quality Improvement and Research in Healthcare GmbH, Göttingen, Germany.
Malte JacobsenDepartment of Internal Medicine I, RWTH Aachen University Hospital, Aachen, Germany.
Dirk Müller-WielandDepartment of Internal Medicine I, RWTH Aachen University Hospital, Aachen, Germany.
Bernhard KulzerDiabetes Center Mergentheim, Bad Mergentheim, Germany.
Lutz HeinemannProfil Institut für Stoffwechselforschung GmbH, Neuss, Germany.ORCID 0000-0003-2493-1304

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDigital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications.

methodsThis article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe.

resultsThe option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes.

conclusionThe DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care.

Indexed as

Diabetes MellitusDigital HealthEuropeGermanyHealth PersonnelHumansclinical trialsdigital healthevidenceGermanyreimbursementvalue-based healthcare

Identifiers

PMID36059268
PMCPMC10973846

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.