Evidence map›Paper›PMID 38789620›Full record

ReviewNPJ digital medicine2024

The three-year evolution of Germany's Digital Therapeutics reimbursement program and its path forward.

Linea Schmidt, Marc Pawlitzki, Bernhard Y Renard, Sven G Meuth, Lars Masanneck

Abstract readReview
In one paragraph

Review in NPJ digital medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing 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

43 citing papers in PubMed.

  1. Article
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  9. Diving into the Regulatory Landscape of Digital Therapeutics.Therapeutic innovation & regulatory science · 2026
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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

5 authors.

Linea SchmidtHasso Plattner Institute, Digital Engineering Faculty, University of Potsdam, Potsdam, Germany.ORCID http://orcid.org/0009-0006-3014-4058
Marc PawlitzkiDepartment of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Bernhard Y RenardHasso Plattner Institute, Digital Engineering Faculty, University of Potsdam, Potsdam, Germany.ORCID http://orcid.org/0000-0003-4589-9809
Sven G MeuthDepartment of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Lars MasanneckDepartment of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. lars.masanneck@med.uni-duesseldorf.de.ORCID http://orcid.org/0000-0003-2496-1415

Funding

Deutsche Forschungsgemeinschaft (German Research Foundation) 493659010
6 · The paper itself

Abstract

The 2019 German Digital Healthcare Act introduced the Digital Health Application program, known in German as 'Digitale Gesundheitsanwendungen' (DiGA). The program has established a pioneering model for integrating Digital Therapeutics (DTx) into a healthcare system with scalable and effective reimbursement strategies. To date, the continuous upward trend enabled by this framework has resulted in more than 374,000 DiGA prescriptions, increasingly cementing its role in the German healthcare system. This perspective provides a synthesis of the DiGA program's evolution since its inception three years ago, highlighting trends regarding prescriptions and pricing as well as criticisms and identified shortcomings. It further discusses forthcoming legislative amendments, including the anticipated integration of higher-risk medical devices, which have the potential to significantly transform the program. Despite encountering challenges related to effectiveness, evidence requirements, and integration within the healthcare system, the DiGA program continues to evolve and serves as a seminal example for the integration of DTx, offering valuable insights for healthcare systems globally.

Identifiers

PMID38789620
PMCPMC11126413

What OpenQuestion holds

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Registered trials

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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.