Press

Press release · Tübingen, 1 September 2026

DiGAs — much better than their reputation

Convincing efficacy evidence demonstrated for the large majority of permanently listed DiGAs

Critics should read the scientific publications

Tübingen, 1 September 2026. More than one million people with statutory health insurance are using or have used state-of-the-art DiGAs (also known as apps on prescription) to treat or support the treatment of their condition: from depression to obesity – from back pain to tinnitus; the spectrum of DiGAs prescribed by general practitioners or specialists is broad. Are or were these DiGAs ineffective? Time and again, leading healthcare stakeholders voice this opinion. “No demonstrable improvement in care”: most recently AOK board chair Reimann. Recent extensive analyses by the ZCRI (HPZenner Clinical Research Institute) in Tübingen come to a very different conclusion: at least 83% of permanently BfArM-listed DiGAs meet the most rigorous scientific criteria for proof of efficacy. And: for the large majority of digital health applications permanently listed in the DiGA directory, convincing scientific evidence of efficacy is publicly available. The investigation evaluated publicly accessible full texts of peer-reviewed scientific publications as well as accessible, reviewed BfArM reports.

For permanently listed DiGAs, the results thus contradict sweeping public statements claiming that the efficacy of DiGAs is generally unproven or insufficiently proven. According to the analysis, the published clinical data — with few exceptions — meet high scientific standards and offer physicians a reliable basis for clinical decisions. But all other stakeholders, too, the analysis finds, are well advised to read the scientific publications before issuing their own statements.

Peer-reviewed publications are decisive

The analysis examined publications and reviewed reports on all 47 DiGAs permanently listed as of October 2025. It was based on a systematic literature search in, among others, MEDLINE (PubMed), Current Contents, CC Med and GMS (LIVIVO) as well as Google Scholar. Levels of evidence were graded according to Oxford CEBM; both statistical significance and effect sizes were taken into account.

For numerous DiGAs, group-controlled studies show high or medium effect sizes. The analysis reports high effect sizes, for example, for applications in the areas of anxiety disorders, depression, diabetes, stress and burnout, bladder/prostate, back pain, smoking cessation, sleep disorders and tinnitus.

At the same time, the investigation reveals a significant gap: for 18 DiGAs, no peer-reviewed publications were available at the time of the investigation in October 2025. Their permanent listing evidently rests on reports available only to the BfArM. Physicians thus lack a publicly accessible scientific basis for assessing efficacy themselves and making a well-founded prescribing decision.

Permanent listing alone is no substitute for published evidence

The analysis draws a clear conclusion: permanent inclusion in the DiGA directory alone cannot replace promptly published evidence. For acceptance in medical care, it is crucial that the underlying results are published in a way that is comprehensible and scientifically verifiable for prescribers as well.

As a practicable approach, the analysis proposes that manufacturers make the final version of the study report submitted to the BfArM publicly available, for example on the homepage of the respective DiGA. In this way, physicians could obtain a reviewed and citable basis for decision-making even when no publication in a scientific journal is yet available.

Transparency strengthens trust in digital health applications

For future development, the analysis recommends consistently expanding the published evidence base. After listing, peer-reviewed results should be published promptly, and effect sizes should be systematically calculated and reported. In addition, studies with longer observation periods as well as real-world observational studies would be desirable.

Conclusion: The publicly available body of studies shows convincing efficacy evidence at a high scientific level for the vast majority of the DiGAs examined. At the same time, some of the applications show a considerable need to catch up on publication. More transparency would make prescribing decisions easier for physicians and, at the same time, strengthen trust in the DiGA directory.

Source:
DiGA Short Report – Publicly available efficacy data as a basis for evidence-based medical prescribing, ZCRI Analyses 8.1 (2026), H.P. Zenner Clinical Research Institute.
PDF: English · German

HPZenner Clinical Research Institute (ZCRI)

We are specialists in clinical evaluations and clinical trials as well as in health-economic and outcome analyses for and about the healthcare industry.

Prof. Dr. Hans-Peter Zenner, MBA
HPZenner Clinical Research Institute (ZCRI)
Prof. Dr. H.P. Zenner GmbH
Bismarckstr. 66
72072 Tübingen
Tel. +49 170 99 66 256
margret.fritz@hpzenner.com