Bfarm Digital Health Application Process
Listing Websites about Bfarm Digital Health Application Process
BfArM - Digital Health Applications (DiGA)
(8 days ago) WebThe BfArM has prepared a guide with important information on process sequence, application procedure and the provision of evidence. The Fast-Track Process for …
https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html
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BfArM Guidance on Fast-Track Process for Digital Health …
(3 days ago) WebThe application process for the Digital Health Applications directory is a detailed and structured procedure, exclusively conducted through the BfArM application …
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BfArM Guidance on Fast-Track Process for Digital Health …
(6 days ago) WebThe application for this extension, along with the necessary justification, must be submitted to the BfArM a minimum of three months before the test is scheduled …
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DiGA – A Chance for the German Healthcare System - PMC
(3 days ago) WebDiGA is a digital health application that has successfully passed the evaluation process at BfArM and is thus listed in the agency’s official DiGA directory. In …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725763/
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Advancing digital health applications: priorities for innovation in
(3 days ago) WebIn 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the …
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(21)00292-2/fulltext
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Full article: DiGA – A Chance for the German Healthcare System
(6 days ago) WebDiGA is a digital health application that has successfully passed the evaluation process at BfArM and is thus listed in the agency’s official DiGA directory. In …
https://www.tandfonline.com/doi/full/10.1080/21614083.2021.2014047
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The Fast-Track Process for DiGA - BfArM
(7 days ago) Weblisting in a directory of reimbursable digital health applications (DiGA directory, in the following also only called directory). The procedure is designed as a fast-track process: …
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Digital Health Applications: DiGAs—Pathway to Reimbursement
(1 days ago) WebThe entire process from application to inclusion in the DiGA register and thus reimbursement by the statutory health insurance is called ‘fast-track procedure’. …
https://link.springer.com/chapter/10.1007/978-3-030-94025-6_4
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DiGA – A Chance for the German Healthcare System
(5 days ago) WebDiGA is a digital health application that has success-fully passed the evaluation process at BfArM and is thus listed in the agency’s official DiGA directory. In principle, …
https://www.tandfonline.com/doi/pdf/10.1080/21614083.2021.2014047
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BfArM Guidance on Fast-Track Process for Digital Health …
(9 days ago) WebThe German regulating authority in the sphere of healthcare products (BfArM) has published a guidance document dedicated to the regulatory requirements …
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DiGA: Apps on prescription gesund.bund.de
(8 days ago) WebThe Digital Healthcare Act (DVG) allows doctors and psychotherapists to prescribe a suitable digital health application (DiGA) as needed. Only apps listed in the directory …
https://gesund.bund.de/en/digital-health-applications-diga
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Digital health applications and the fast-track pathway to public …
(8 days ago) WebObjectives Evidence-based decision-making is the sine qua non for safe and effective patient care and the long-term functioning of health systems. Since 2020 …
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08500-6
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#bfarmDigitalFuture - BfArM - Startseite
(5 days ago) Web“new BfArM”. Digital health applications open up a wide range of possibilities to support the recognition and treatment of diseases and to help people on their way to a self …
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Evidence requirements of permanently listed digital health …
(8 days ago) WebBackground With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. …
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09287-w
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BfArM Guidance on Fast-Track Process for Digital Health …
(3 days ago) WebThe Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a guidance …
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Health Economics - National Center for Biotechnology Information
(3 days ago) WebThe German Digital Health Application (DiGA) Guide (BfArM, 2020b) is the most precise and sets a preference for (possibly domestically generated) real‐world data …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9545972/
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Digital health applications (DiGA) - infoteam
(8 days ago) WebDigital health applications (DiGA) Apps on prescription: Digital health applications (DiGA) are medical devices of class I or IIa that are subject to approval – but …
https://infoteam.de/en/our-know-how/digital-health-applications-diga
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BfArM Guidance on Fast-Track Process for Digital Health …
(8 days ago) WebThe Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products has published a guidance …
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2 Years After Germany’s Regulation For Digital Health Apps What …
(5 days ago) WebThis promotion of digital innovation has enabled the transfer of successful pilot projects into regular provision of care, expanding the options to use health data for …
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