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R2G Report: Entering the German market with a digital health solution


R2R managing director, Ralf Jahns
Germany is set to enter an era of digital health over next few years, making it a significant market for health tech solutions.
Digital health analysis and consultancy firm Research2Guidance (R2G) has published a white paper examining the challenges and opportunities, in light of Germany’s new digital health application (DiGA) fast track approval process.
To gain DiGA approval, providers must prove to the German Federal Institute for Drugs and Medical Devices (BfArM), that their apps can improve patient care and meet specified criteria.
However, R2G’s report says that attaining DiGA status alone is not enough to ensure success in the German market and providers must also develop a comprehensive market entry strategy to drive adoption. It recommends measures such as providing high quality clinical evidence, selecting distribution channels and planning provider outreach. ....

Ralf Gordon Jahns , German Federal Institute For Drugs , Health Innovation Hub , Health Care Act , German Federal Institute , Medical Devices , Gordon Jahns , ஜெர்மன் கூட்டாட்சியின் நிறுவனம் க்கு மருந்துகள் , ஆரோக்கியம் கண்டுபிடிப்பு மையம் , ஆரோக்கியம் பராமரிப்பு நாடகம் , ஜெர்மன் கூட்டாட்சியின் நிறுவனம் , மருத்துவ சாதனங்கள் ,

Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap | MoFo Life Sciences


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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program. 
Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD. ....

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