Bfarm Digital Health Database
Listing Websites about Bfarm Digital Health Database
BfArM - Public databases
(9 days ago) WEBFor private customers within the EU, prices are increased by the VAT rate applicable in their country. Table 2: Prices for flat fees, valid from 02.01.2019, excluding VAT. Database …
https://www.bfarm.de/EN/Medical-devices/Tasks/DMIDS/Public-databases/_node.html
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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 …
(6 days ago) WEBEncrypted Data Storage: Data on servers (e.g., in clouds) must be encrypted. The encryption method (hard drive encryption, database encryption, etc.) …
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Germany’s digital health reforms in the COVID-19 era: …
(3 days ago) WEBAt the request of the manufacturer, the BfArM will assess whether the manufacturer has provided proof that their digital health application fulfills the following …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351985/
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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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BfArM Guidance & Regulatory Requirements for DiGA RegDesk
(3 days ago) WEBThe German regulating authority in the sphere of healthcare products (BfArM) has published a guidance document dedicated to digital health applications …
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Digital health apps in Germany - An update on the DiGA journey
(Just Now) WEBDigital therapeutics, or Digital Health Applications (DiGA), are apps for the detection, monitoring, treatment, or alleviation of medical conditions. Therefore, the …
https://www.healthcareitnews.com/news/emea/digital-health-apps-germany-update-diga-journey
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The German Fast Track Toward Reimbursement of Digital …
(3 days ago) WEBThe German Digital Healthcare Act (DVG) was enacted in 2019 aiming at increasing the adoption in the German healthcare system of high-quality DHT from all …
https://journals.sagepub.com/doi/full/10.1177/19322968221121660
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Market access and value-based pricing of digital health …
(3 days ago) WEBIn December 2019, the Digital Health Care Act (“Digitale-Versorgung-Gesetz”) introduced a general entitlement to the provision and reimbursement of digital …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9195309/
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DiGA: How Germany Channeled Digital Health Apps Into …
(9 days ago) WEBCurrently, there are 33 DiGAs listed on the official BfArM registry: 13 are permanent and 20 are preliminarily listed. All applications that receive DiGA approval …
https://www.linkedin.com/pulse/diga-how-germany-channeled-digital-health-apps-its-mesk%C3%B3-md-phd
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BfArM - Medicinal products
(3 days ago) WEBTasks. Both marketing authorisation and registration of medicinal products belong to the main tasks of the BfArM. Medicinal products are substances that are used to treat …
https://www.bfarm.de/EN/Medicinal-products/_node.html
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Dynamic HTA for digital health solutions: opportunities and …
(3 days ago) WEBAs of October 10, 2023, 49 DiGA were listed in the official Directory (“DiGA Register” or registry of approved digital health applications) maintained by Germany’s Federal …
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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 …
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 in the sphere of healthcare products (BfArM) has published a guidance document dedicated to the regulatory requirements …
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One year of digital health applications (DiGA) in Germany
(7 days ago) WEBUsage of digital health applications/medical apps in routine rheumatology care. Most (86%, n = 60/70) believe that using DiGA/medical apps would at least …
https://www.frontiersin.org/articles/10.3389/fmed.2022.1000668/full
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BfArM - Homepage
(9 days ago) WEBThe BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency ( EMA ), …
https://www.bfarm.de/EN/Home/_node.html
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EU Health Data Space: more efficient treatments and life-saving
(8 days ago) WEBOn Wednesday, MEPs voted with 445 in favour and 142 against (39 abstentions) to approve the inter-institutional agreement on establishing a European …
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Can Hospitals Create Better Digital Health Startups? AHA
(3 days ago) WEBThe startup incubation studio Aegis Ventures recently gained some important backers for its model to co-develop, invest in and deploy tech solutions that address …
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World's Best Digital Health Companies 2024 - Data Analytics
(Just Now) WEBData intelligence platform Statista predicts the global digital health market will exhibit a compound annual growth rate of more than 9 percent through 2028, when it will arrive at …
https://www.newsweek.com/rankings/worlds-best-digital-health-companies-2024/data-analytics
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Germany’s digital health reforms in the COVID-19 era - Nature
(9 days ago) WEBReimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current …
https://www.nature.com/articles/s41746-020-0306-7
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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 …
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BfArM - Medicinal products information
(7 days ago) WEBThe BfArM provides information on medicinal products for healthcare professionals and consumers. The Public Assessement Reports state the background for scientific …
https://www.bfarm.de/EN/Medicinal-products/Information-on-medicinal-products/_node.html
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Updated FTC Health Breach Notification Rule puts new provisions …
(6 days ago) WEBIt was Shakespeare who said, “Once more unto the breach.” The FTC’s goal is never more unto the breach, but until companies keep health data secure and private, …
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AHRQ guide provides ways to support equity through digital …
(3 days ago) WEBThe Agency for Healthcare Research and Quality recently released a guide to help health systems and other stakeholders assess and advance equity in health care …
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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 …
Category: Medical Show Health
European Health Data Space clears the last hurdle in Parliament
(9 days ago) WEBThe European Parliament adopted on Wednesday (24 April) the European Health Data Space Regulation, a key step for Europe's digital healthcare that should …
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BfArM Guidance on Fast-Track Process for Digital Health …
(Just Now) 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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BfArM - Medical devices
(Just Now) WEBThe tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation ( MDR) ( EU) 2017/745, the Medical Device Law …
https://www.bfarm.de/EN/Medical-devices/_node.html
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