Bfarm Digital Health Application Procedure
Listing Websites about Bfarm Digital Health Application Procedure
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 Digital Health Applications (DiGA) according to Section 139e SGB V. A Guide for Manufacturers, Service Providers and Users PDF, 2MB, File does not meet accessibility standards.
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 …
(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 to conclude. In total, the testing phase can be extended up to 24 months at most. The BfArM offers preliminary information on both content and formal matters through its advisory …
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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 related to the fast-track process for digital health applications (DiGA) intended to be marketed and used in the country.The document provides an overview of the …
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Digital Health Applications: DiGAs—Pathway to …
(1 days ago) WebThe digital health applications must have successfully passed a procedure at the BfArM and be listed in a newly created directory of reimbursable digital health applications, named “DiGA-Verzeichnis”. Footnote 1 The application procedure is designed as a fast-track and takes a maximum of 3 months after receipt of the complete …
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 - 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 principle, innovations in the healthcare system must lead to a noticeable additional value in patient care and to a significant increase in the quality of treatment[ 12 ].
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725763/
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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, innovations in the healthcare system must lead to a noticeable additional value in patient care and
https://www.tandfonline.com/doi/pdf/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: Within a three-month period starting with the filing of the complete application, the BfArM has to assess the DiGA.
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BfArM's application portal for digital health applications
(4 days ago) WebThe BfArM application portal for digital health applications (DiGA) was already launched on 27 May 2020. A further completion guidance for answering the comprehensive catalogue of questions was added during June.
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The three-year evolution of Germany’s Digital Therapeutics
(Just Now) Weba Digital Health Application (DiGA) count in 2022 and 2023 divided by indication group. b Proportion of prescriptions from the overall prescription in the respective years (2022 and 2023) by
https://www.nature.com/articles/s41746-024-01137-1
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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 German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real …
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(21)00292-2/fulltext
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BfArM Guidance on Fast-Track Process for Digital Health …
(9 days ago) WebThe German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere of healthcare products has issued a guidance document dedicated to fast-track pathways for digital health products intended to be marketed and used in the country.. The document provides a general overview of the applicable …
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BfArM’s application procedure for DiGA catalogue starts now.
(6 days ago) WebWith the opening of the DiGA portal, the application procedure for digital health applications is possible as of now. Phone: +49 431 800 147 0. Email: [email protected]. Reimbursement and Market Access Support BfArM’s application procedure for DiGA catalogue starts now.
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DYNAMIC HTA FOR DIGITAL HEALTH SOLUTIONS: …
(8 days ago) Webprocess or state)” and 2) “that the SaMD provides the expected technical and clinical data” (2). (BfArM). These regulated digital health applications are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all of its 73 million patients. The Digital Health Care Application
https://www.hbs.edu/ris/download.aspx?name=DiGA-HTA_updated29Oct2023_CLEAN.pdf
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BfArM - Blog - #5 Tips for DiGA applicants
(Just Now) Web0 consultations for DiGA were held at the BfArM within approximately one year.. For more than a year now, physicians and psychotherapists in Germany have been able to prescribe medical apps and other Digital Health Applications (DiGA).If the diagnosis is appropriate, reimbursement directly from the statutory health insurance is also …
https://www.bfarm.de/EN/News/Blog/_docs/2021-10-06-tipps-diga-antragsteller.html
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Digital Health Applications (DiHA): Approaches to develop a
(7 days ago) WebThe purpose of this paper is to elaborate a concept for a reimbursement process of Digital Health Apps (DiHAs) for Austrian statutory health insurers. As part of this process, we aimed to develop a model to prioritise DiHAs that are directly relevant to the Austrian context based on technical knowledge (e.g., law, IT infrastructure, etc.).
https://www.sciencedirect.com/science/article/pii/S2211883723000564
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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 Digital Health Applications (DiHA, German DiGA) in Germany have been undergoing a systematic pathway to be reimbursed by statutory health insurance (SHI) which is attracting …
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08500-6
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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 document dedicated to the Digital Health Applications (DiGA) and the regulatory framework associated thereto. The document provides an overview of the applicable regulatory …
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Digital Health Applications Ordinance - Johner Institute
(2 days ago) WebThe BfArM writes: “The procedure is designed as a rapid “fast-track” procedure. ISO 27001), another for proof that the digital health application complies with the data security requirements, and a third certificate to prove that the digital health application meets the data protection requirements. Plan accordingly for legacy digital
https://www.johner-institute.com/articles/health-care/digital-health-applications-ordinance/
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Table of content - BfArM
(Just Now) Webto submit an application for the inclusion of a digital health application (DiGA) into the DiGA directory as a basis for reimbursement by the statutory health insurance as part of the fast-track procedure according to the German Social Code Book Five section § 139e (Fünftes Buch Sozialgesetzbuch, § 139e SGB V).
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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 with "fast track" as an additional process option for entry into the BfArM's directory of reimbursable applications.This means that the manufacturers and distributors of DiGA …
https://infoteam.de/en/our-know-how/digital-health-applications-diga
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
(Just Now) Webdrug development or manufacturing process and to the review process. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the “Platform Technology Designation Program.” It does not establish any
https://public-inspection.federalregister.gov/2024-11686.pdf
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