Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.
BMC Health Serv Res
; 23(1): 369, 2023 Apr 17.
Article
em En
| MEDLINE
| ID: mdl-37069592
ABSTRACT
BACKGROUND:
With 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.OBJECTIVE:
The 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.METHODS:
A 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.RESULTS:
All 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.CONCLUSION:
The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.Palavras-chave
Texto completo:
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Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Qualitative_research
Limite:
Humans
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article