Bfarm Digital Health Application Procedure

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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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#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 …

https://www.bfarm.de/SharedDocs/Downloads/EN/BfArM/Publikationen/DigitalFuture.pdf?__blob=publicationFile

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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 …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-timeframes/

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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 …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-temporary-and-permanent-admission/

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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 …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-evidence-studies/

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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 …

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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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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BfArM Guidance on Fast-Track Process for Digital Health …

(3 days ago) WEBThe German regulating authority in the sphere of healthcare products (BfArM – Federal Institute for Drugs and Medical Devices) has published a guidance …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-general-requirements/

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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 …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-life-cycle/

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BfArM Guidance on Fast-Track Process for Digital Health …

(Just Now) WEBApplication Fees and Expenses for DiGA. The BfArM imposes specific fees for processing applications and notifications related to DiGA. These fees are outlined in …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-fees-and-glossary/

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BfArM presents fast track for approval of digital health …

(3 days ago) WEBThe Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the admission of requesting manufacturers’ medical apps as so-called “DiGAs”. With …

https://www.healthcareheads.com/en/news/news-details/bfarm-presents-fast-track-for-approval-of-digital-health-applications-digas-1799

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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 …

https://www.regdesk.co/bfarm-guidance-on-fast-track-process-for-digital-health-applications-data-protection/

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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: …

https://www.healthcareheads.com/en/news/news-details/bfarms-application-procedure-for-diga-catalogue-starts-now-1809

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BfArM - Digital nursing applications (DiPA)

(9 days ago) WEBThe BfArM has prepared a guide with important information on process sequence, application procedure and the provision of evidence. Please note that the DiPA Guide …

https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Nursing-Applications/_node.html

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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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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 …

https://skc-beratung.de/insights/blog/2020/07/Publication_BfArM_application_portal_digital_health_applications.php

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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 …

https://www.johner-institute.com/articles/health-care/digital-health-applications-ordinance/

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