Bfarm Digital Health Application

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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 Digital …

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 German regulating authority of Healthcare Products has published a guidance document dedicated to the regulatory requirements for digital health …

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

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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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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 …

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

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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 …

https://www.nature.com/articles/s41746-024-01137-1

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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 presents fast track for approval of digital health …

(3 days ago) WebThe final version of the Digital Health Application enactment (DiGAV) as well as the corresponding fast track guideline have been published. [Translate to Englisch:] The Federal Institute for Drugs …

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

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Germany’s digital health reforms in the COVID-19 era - Nature

(9 days ago) WebThe BfArM also provides a case report form on its website to help manufacturers assess whether a change to a digital health application is “significant” 12.

https://www.nature.com/articles/s41746-020-0306-7

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Digital Health Applications: DiGAs—Pathway to Reimbursement

(1 days ago) WebThe documentation of lifestyle factors in the diary enables individual trigger management. First registration in the DiGA list was on 16 December 2020. M-sense …

https://link.springer.com/chapter/10.1007/978-3-030-94025-6_4

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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: …

https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile&v=2&ref=blog.chino.io

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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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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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Digital Health Applications (DiHA): Approaches to develop a

(7 days ago) WebThe Austrian Health Literacy Survey 2020 [25] shows that the greatest challenge (compared to general health literacy) lies in the area of navigation skills (i.e., …

https://www.sciencedirect.com/science/article/pii/S2211883723000564

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Integration of Digital Health Tools into Clinical Practice

(8 days ago) WebProject Start Date: May 1, 2018 Project End Date: February 28, 2022. While FDA funding of this project has ended, the research continues to evolve and result in …

https://www.fda.gov/science-research/advancing-regulatory-science/developing-frameworks-and-tools-integration-digital-health-tools-clinical-practice

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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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Management of Rheumatoid Arthritis With a Digital Health …

(8 days ago) WebLi et al. proposed a digital health application for the follow-up and diagnosis of rheumatoid arthritis (RA) and showed the clinical value and prediction of this …

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2803893

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BfArM - Homepage - The Fast-Track Process for Digital Health

(5 days ago) WebThe Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V. A Guide for Manufacturers, Service Providers and Users. Tasks …

https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.html

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How DOs can be at the forefront of the digital health revolution

(3 days ago) WebGuided by subject-matter experts, it will create a hub for networking, professional development, knowledge-sharing and collaboration on a national level to …

https://thedo.osteopathic.org/2024/05/how-dos-can-be-at-the-forefront-of-the-digital-health-revolution/

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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 …

https://www.bfarm.de/EN/News/Blog/_docs/2021-10-06-tipps-diga-antragsteller.html

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Georgia Department of Community Health Application For GA …

(8 days ago) Web13. Please sign and date this application (TO BE SIGNED BY POLICYHOLDER ONLY) Signature of applicant Date Fax completed application toll-free to 1.800.817.1769, E …

https://medicaid.georgia.gov/sites/medicaid.georgia.gov/files/related_files/document/GA-HIPP-APPLICATION.pdf

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Planning for Healthy Babies - Georgia Department of …

(6 days ago) WebGeorgia Department of Community Health 2 Peachtree Street NW, Atlanta, GA 30303 www.dch.georgia.gov 404-656-4507 Please be sure to answer all the questions on …

https://dch.georgia.gov/sites/dch.georgia.gov/files/related_files/document/17P4HB1.pdf

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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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Datavant The Leader in Data Logistics for Healthcare

(5 days ago) WebDatavant is a data logistics company for healthcare whose products and solutions enable organizations to move and connect data securely.Through proprietary technology, the …

https://www.datavant.com/

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Nutrients Free Full-Text Assessing the Level of Knowledge

(1 days ago) WebThe level of NCP implementation varies across countries due to differences identified in major components of health systems such as infrastructures, legislation, …

https://www.mdpi.com/2072-6643/16/11/1716

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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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