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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.
PKV ist bei Erstattung neuer Leistungen schneller
aerztezeitung.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from aerztezeitung.de Daily Mail and Mail on Sunday newspapers.
Digitale Gesundheitsanwendungen - gesund durch Apps auf Rezept? Marktcheck im SWR Fernsehen
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08:49 AM
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.
deprexis im DiGA-Verzeichnis gelistet: GKV erstattet Online-Therapieprogramm bei Depressionen
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