Negotiamini Media
Truth is Powerful

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

16

EMEA

Government & Policy

Digital Medicine Week’s International Summit has been hearing why digital developers should try to board Germany’s new DiGA Fast-Track process and get their products to market. Digital Medicine Week’s International Summit has been hearing why digital developers should try to board Germany’s new DiGA Fast-Track and what evidence they need to provide to get their products to market. 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. Fifty-five medical apps to help treat a range of conditions, such as tinnitus and insomnia, have already been listed.

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 […]

Click here to view original web page at www.healthcareitnews.com

Comments
Loading...

This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Accept Read More