ReviewBMC health services research2023
Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.
Review in BMC health services research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Digital Therapeutics for People with Schizophrenia Spectrum Disorders: A Systematic Literature Review of Their Effect on Symptoms and Functioning.Schizophrenia bulletin · 2026Pooled it
- Effectiveness of digital health applications on the quality of life in patients with overweight or obesity: a systematic review.Archives of public health = Archives belges de sante publique · 2025Pooled it
- What Users Say About Reimbursable Digital Therapeutics in Germany: Large-Scale App Store Review Analysis Using a Large Language Model.JMIR human factors · 2026Article
- Assessing the Quality of Evidence Regarding Permanently Listed Digital Health Applications (DiGAs) in Germany: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- National scale up of PROM based monitoring after joint replacement in Germany.npj health systems · 2026Article
- Real-world data on uptake and use of digital mental health interventions among waitlisted patients with various mental disorders.Internet interventions · 2026Article
- Integration of Digital Therapeutics Into Occupational Rehabilitation in Germany: Multilevel Simulation Study.Journal of medical Internet research · 2026Article
- A dataset of digital therapeutic device approvals to support regulatory decisions and industry research.Scientific data · 2026Article
- [DiGA, non-DiGA and realities of practice : A questionnaire study on opportunities and challenges of health apps in the field of mental healthcare].Der Nervenarzt · 2026Article
- Comparing mental health professionals' willingness to use digital therapeutics: a cross-national survey in South Korea and Germany.BMC health services research · 2026Article
- Development and evaluation of a web-based toolkit to inform mental health professionals about digital mental health interventions for eating disorders.Journal of eating disorders · 2026Article
- Perspectives on digital therapeutic prescribing: a qualitative study among German psychological psychotherapists.Frontiers in digital health · 2026Article
- Editorial: Beyond the hype: a global perspective on the real-world utility of AI in healthcare research and service delivery.Frontiers in health services · 2026Article
- Prescribing Experiences, Potentials, and Challenges of Digital Health Applications in the Field of Hormones and Metabolism: Cross-Sectional Survey Study of Health Care Providers in Germany.JMIR formative research · 2025Article
- Genie in the bottle? a qualitative study of general practitioners' perspectives and information needs concerning digital mental health applications in Germany.BMC primary care · 2025Article
- Digital Tinnitus Counseling in Clinical Practice: A Multicenter Randomized Controlled Trial.Audiology research · 2025Article
- Equity by design principles for digital health interventions.International journal for equity in health · 2025Article
- Wearables in ADHD: Monitoring and Intervention-Where Are We Now?Diagnostics (Basel, Switzerland) · 2025Review
- [Digital health applications from a regulatory perspective-Experiences and current developments].Der Nervenarzt · 2025Article
- Digital empowerment on hold: DiGA adoption gaps-a German national cross-sectional patient survey study.Rheumatology international · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWith its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking.
objectiveThe study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory.
methodsA multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them.
resultsAll DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence.
conclusionThe results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.