Innovationsunterstützung im BfArM – Erfahrungen aus den Beratungen zu digitalen Gesundheitsanwendungen (DiGA)

Löbker, Wiebke; Böhmer, Anne C.; Höfgen, Barbara

doi:10.1007/s00103-021-03410-0

Cited by 4 publications

(1 citation statement)

References 2 publications

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“…Löbker et al (2021) reported on their experience from consultations on DiGA showing most (80%) of DiGA directory application manufacturers have taken advantage of a consultation during the process. The rate of withdrawn/rejected applications was higher, if manufacturers had not sought advice (63%), compared to manufacturers who had previously discussed key content with BfArM (35%) [ 9 ]. Düvel et al (2021) qualitatively identified potential solutions to improve DiGA access to statutory standard care, recommending a central advisory office [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Mäder

Timpel²,

Schönfelder³

et al. 2023

BMC Health Serv Res

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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.

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Section: Introductionmentioning

confidence: 99%

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Mäder

Timpel²,

Schönfelder³

et al. 2023

BMC Health Serv Res

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Digitalisierung und Telerehabilitation

Pförringer

Back²

2022

Unfallchirurgie

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Digitalisierung nimmt einen kontinuierlich wachsenden Stellenwert in der Medizin ein. Prozesse werden optimiert, Daten digital erfasst, analysiert und archiviert. Wenngleich in Deutschland noch ein vergleichsweise großer Aufholbedarf existiert, befinden wir uns auf einem soliden Weg. Mit der Etablierung des European Health Data Space (EHDS) wird in Brüssel ein Meilenstein für den sicheren Austausch von Daten gesetzt. Digitalisierung beinhaltet das Potenzial für umfangreiche Prozessoptimierung. Während derzeit ein Gros der Arbeitszeit deutscher Ärzte von Bürokratie verschlungen wird, kann ein relevanter Anteil dieser Arbeit durch digitale Lösungen effizienter erledigt werden. Die Digitalisierung ersetzt nicht den Arzt, sondern unterstützt ihn, zum Wohle des Patienten. Zahlreiche Wege sowie damit verbundene Transport- und Logistikkosten sind vermeidbar bzw. durch digitale Ergänzungen und neue Darreichungsformen auf digitalem Wege adressierbar. Dies schont Ressourcen, spart Zeit und optimiert die Versorgung. Die Offenheit und Affinität von Ärzten und Patienten für das Thema hängen bedeutend von der Digital Health Literacy, d. h. dem Verständnis und Wissen zum Thema, ab. Kontinuierlich Ängste abzubauen und Akzeptanz zu steigern, ist das Ziel der kommenden Jahre. Zudem bedarf es relevanter Investitionen in die technische Grundausstattung auf Soft- und Hardwareseite.

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Conceptualizing the landscape of digital health entrepreneurship: a systematic review and research agenda

Weimar,

Martjan,

Terzidis

2024

Manag Rev Q

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Digital health, which encompasses the use of digital technology to enhance and support healthcare, can potentially transform the healthcare industry. As healthcare systems struggle to provide high-quality care, entrepreneurs and startups have turned to digital health technology to create innovative products and services that aim at improving healthcare outcomes and reducing costs. This has made digital health entrepreneurship a major driving force for achieving good health and high-quality care. The study aims to analyze the current state of research in digital health entrepreneurship by identifying contributing disciplines and common research themes. A comprehensive literature review based on state-of-the-art definitions of digital health entrepreneurship was conducted to achieve this goal. A total of 164 articles met the final inclusion criteria, and the subsequent inductive analysis revealed the presence of three contributing disciplines and ten distinct themes: Academia Transfer and Education, Ecosystem and Stakeholder, Product and Business Development, Business Model, Classification, Management and Strategy, Regulation, Digital Technology, Implementation and Adoption, and Evaluation. These themes were organized into a conceptual framework depicting the internal and external building blocks of digital health entrepreneurship. The review highlights the importance of a structured understanding of the industry, including its business models and regulatory environment, as well as the role of the various healthcare stakeholders. This analysis can guide researchers and entrepreneurs seeking to navigate the digital health landscape and proposes further research avenues.

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Innovationsunterstützung im BfArM – Erfahrungen aus den Beratungen zu digitalen Gesundheitsanwendungen (DiGA)

Cited by 4 publications

References 2 publications

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis

Digitalisierung und Telerehabilitation

Conceptualizing the landscape of digital health entrepreneurship: a systematic review and research agenda

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