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Germany's Digital Medical Device Regulations A Framework For The World To Follow Part II


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 ....

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