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 (s) …
https://www.bfarm.de/EN/Medical-devices/Tasks/DMIDS/Public-databases/_node.html
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BfArM - Digital Health Applications (DiGA) - Interesting …
(9 days ago) WebData processing outside Germany. In the following, the BfArM presents its current legal position with regard to the processing of personal data outside Germany in connection …
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#bfarmDigitalFuture - BfArM - Startseite
(5 days ago) Webthat health data can be used across national borders, for example for research purposes.” Patient-oriented use of health data for Europe in combination with EU-wide cooperation …
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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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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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Digital health applications and the fast-track pathway to …
(8 days ago) WebData used in the study includes (1) data from published clinical trials and (2) data with regard to characteristics of Digital Health Applications. The latter one was …
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08500-6
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Evidence requirements of permanently listed digital …
(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 …
(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.) and …
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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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Germany becomes the first country in the world to reimburse the
(6 days ago) WebDiGA Directory. If the assessment procedure has a positive outcome, the DiGA is approved and added to the DiGA Directory, the official BfArM’s database …
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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: 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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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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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 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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The German Fast Track Toward Reimbursement of Digital Health
(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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Access and reimbursement pathways for digital health solutions …
(3 days ago) WebNot secondary, it is the need to guarantee information security and allow to patient real control over their own health data. The global digital health market was …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986593/
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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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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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DiGA: How Germany Channeled Digital Health Apps Into Its
(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 are …
https://www.linkedin.com/pulse/diga-how-germany-channeled-digital-health-apps-its-mesk%C3%B3-md-phd
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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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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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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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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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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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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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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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