Bfarm Digital Health Database

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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.) and …

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

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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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Digital health apps in Germany - An update on the …

(Just Now) WebDigital therapeutics, or Digital Health Applications (DiGA), are apps for the detection, monitoring, treatment, or alleviation of medical conditions. Therefore, the BfArM emphasis on the interoperability of …

https://www.healthcareitnews.com/news/emea/digital-health-apps-germany-update-diga-journey

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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 …

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

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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 are …

https://www.linkedin.com/pulse/diga-how-germany-channeled-digital-health-apps-its-mesk%C3%B3-md-phd

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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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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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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 …

https://www.obelis.net/news/germany-becomes-the-first-country-in-the-world-to-reimburse-the-prescription-of-digital-health-applications/

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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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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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Evidence requirements of permanently listed digital health …

(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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Digital Health Applications (DiGA) - BAYOOMED

(3 days ago) WebAs medical devices, they must be CE-marked, are subject to the requirements of the Digital Health Applications Ordinance (DiGAV), and are included in the DiGA directory after …

https://www.bayoomed.com/en/diga/

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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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Privacy Challenges for Digital Health Applications (DiGA)

(7 days ago) WebLawfulness and purpose limitation (Part 2, Sections 2 and 4 of the BfArM data protection criteria) The digital health application may only process data for certain …

https://planit.legal/en/privacy-challenges-for-digital-health-applications-diga-part-2/

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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 …

https://www.europarl.europa.eu/news/en/press-room/20240419IPR20573/eu-health-data-space-more-efficient-treatments-and-life-saving-research

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Army Unveils New Electronic Health Data Capture Software

(5 days ago) WebThe U.S. Army has launched a new program to modernize the service branch's efforts to develop, integrate and field software capabilities to capture electronic …

https://executivegov.com/2024/04/army-transitions-to-new-electronic-health-data-capture-software-program/

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AHRQ guide provides ways to support equity through digital …

(3 days ago) WebApr 25, 2024 - 04:01 PM. The Agency for Healthcare Research and Quality recently released a guide to help health systems and other stakeholders assess and …

https://www.aha.org/news/headline/2024-04-25-ahrq-guide-provides-ways-support-equity-through-digital-health-care-technology

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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 (DiGA).The …

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

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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, …

https://www.ftc.gov/business-guidance/blog/2024/04/updated-ftc-health-breach-notification-rule-puts-new-provisions-place-protect-users-health-apps

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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 …

https://www.euractiv.com/section/health-consumers/news/european-health-data-space-clears-the-last-hurdle-in-parliament/

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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 …

https://www.aha.org/aha-center-health-innovation-market-scan/2024-04-23-can-hospitals-create-better-digital-health-startups

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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 …

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

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World's Best Digital Health Companies 2024 - Data Analytics

(Just Now) WebDigital Health companies are defined as companies who primarily offer digital products or services within the healthcare sector. In total, 400 companies from over 35 different …

https://www.newsweek.com/rankings/worlds-best-digital-health-companies-2024/data-analytics

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European Commission releases Q&A on Health Data Space proposal

(3 days ago) Webschedule Apr 26, 2024. queue Save This. print. The European Commission released a Q&A on the European Health Data Space proposal to advance digital health …

https://iapp.org/news/a/european-commission-releases-qa-on-ehds-proposal/

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Billions of scraped Discord messages up for sale Malwarebytes

(5 days ago) WebPosted: April 22, 2024 by Pieter Arntz. Four billions public Discord messages are for sale on an internet scraping service called Spy.pet. At first sight there doesn’t …

https://www.malwarebytes.com/blog/news/2024/04/billions-of-scraped-discord-messages-up-for-sale

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