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Are You Ready For The FDA's "Data Effect" Tsunami 8 Steps To Prepare


Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
By Matt Collins, CEO, Cignyl; and John Giantsidis, president, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging public health threats.
This sounds very noble, and using data as the basis of the FDA s regulatory decision-making seems to be an improvement. So, why would this be a tsunami for biotechnology, pharmaceutical, and medical device manufacturers? Do not misunderstand, data turned into knowledge improves understanding, decision-making, and, ultimately, outcomes. Businesses have learned this and are continuously improving their use of analytics as a competitive differentiator. However ....

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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 ....

United States , John Giantsidis , Medizinprodukte Bfar , Cyberacta Inc , Institute For Drugs , Information Security And Service Management , Clark University , George Washington University , Party Software , Florida Bar Committee On Technology , University Of New Hampshire , German Federal Office For Information Security Bundesamt , Digital Healthcare Act , Federal Institute , Medical Devices , With Very High Protection , German Federal Office , Information Security , Grundschutz Catalogues , Florida Bar , Cyber Aux , Juris Doctor , New Hampshire , Cybersecurity Policy , George Washington , ஒன்றுபட்டது மாநிலங்களில் ,

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


Germany s Digital Medical Device Regulations: A Framework For The World To Follow, Part I
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. I will give an overview of the situation and will cover the many privacy requirements noted in the new guide in ....

United States , John Giantsidis , Medizinprodukte Bfar , Clark University , Cyberacta Inc , George Washington University , European Union , Institute For Drugs , Florida Bar Committee On Technology , University Of New Hampshire , Digital Healthcare Act , Federal Institute , Medical Devices , Medical Device Directive , Medical Device Regulation , Data Protection Regulation , Florida Bar , Cyber Aux , Juris Doctor , New Hampshire , Cybersecurity Policy , George Washington , ஒன்றுபட்டது மாநிலங்களில் , கிளார்க் பல்கலைக்கழகம் , ஜார்ஜ் வாஷிங்டன் பல்கலைக்கழகம் , ஐரோப்பிய தொழிற்சங்கம் ,