May 5, 2021
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.
Legislative changes under the 2019...
March 18, 2021
A recent document released by the German Federal Institute for Drugs and Medical Devices (BfArM) has revealed that despite the invalidated Privacy Shield there are exemptions in place for Germany to allow data storage from digital health applications, so-called DiGAs, in European and even US clouds under specific terms.
MobiHealthNews has looked into what it means for DiGA developers and startups...
March 5, 2021
Germany is the first country in the world to prescribe digital apps – DiGAs, as the Germans call them, and reimburse them through the statutory health system as reported in Healthcare IT News.
To drive innovation and speed up the regulatory process around those digital health applications, Germany has introduced a 'Fast Track' for approval, testing, piloting and evaluation of these apps – which...