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What evidence do you need to board Germany's DiGA Fast-Track?


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. ....

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