The market access challenge
Digital health technologies are failing to reach their potential to boost the quality and efficiency of healthcare systems, largely because of a lack of dedicated access pathways or value assessment processes
Digital health is an emerging and rapidly developing field with the potential to increase the quality and efficiency of healthcare systems. The rise of digital health technologies (DHTs) has been driven by an increase in non-communicable diseases and a desire by patients to take a more active role in the management of their condition and is now being accelerated by the COVID-19 pandemic. DHTs have the potential to allow payers and manufacturers to track patient outcomes and adherence better, faster and more accurately, and hence support wider adoption of value-based healthcare models.
Value-based care implies radical, even disruptive changes to the current practice, say Paulus Torkki, associate professor of healthcare operations management at University of Helsinki and Marianna Imenokhoeva, founder of LinktoMedicine and HIMSS Future50 Leader.
Germany s Digital Medical Device Regulations A Framework For The World To Follow Part III meddeviceonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from meddeviceonline.com Daily Mail and Mail on Sunday newspapers.
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Digital healthcare regulators, experts and developers discussed the Digital Health Applications (DiGA) process, and yesterday’s (24 Feb) Evidence Con session was designed to help innovators find out more about the new evidence requirements for the assessment of digital products in Germany.
The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the DiGA Fast-Track, which is now up and running. Eleven medical apps to help treat a range of conditions, such as tinnitus and insomnia, have already been listed - with an additional 55 in the certfication process.
WHY IT MATTERS
The DiGA Fast-Track was created by the 2019 Digital Healthcare Act and legislative changes mean that apps can now be prescribed by doctors and costs will be reimbursed through German health insurance. However, there are legal and regulatory hurdles to overcome before the apps can be listed and Data Protection Standards within German healthcare are strict.
Germany s Digital Medical Device Regulations: A Framework For The World To Follow, Part II
Germany’s Digital Healthcare Act came into effect on December 19, 2019, introducing the “app on prescription” as part of healthcare provided to patients through digital health applications (in German: “digitale Gesundheitsanwendungen,” hereinafter DiGA). The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, or the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for DiGA manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In Part 1 of this article series, I gave an overview of the situation and covered the many privacy requirements noted in the new guide. In this