On 5 October, the Digital Healthcare Act (DVG) officially granted doctors in Germany permission to prescribe apps to their patients for the first time.
Currently, two apps have been approved, making it the first country to prescribe insured health apps.
The first apps were unveiled last week after making it through the test procedure from the Federal Institute for Drugs and Medical Devices (BfArM). They are the Kalmeda app, which aims to help with tinnitus, and Velibra, a therapy programme for anxiety disorders.
WHY IT MATTERS
While only 6% of patients have used paid medical apps in the past, almost 60% would use these digital tools if their physician prescribed them and the costs were covered by the payer.
The costs are to be covered by the statutory health insurance (GKV) in what is thought to be a world first.
THE LARGER CONTEXT
Last year, the German parliament passed new rules supporting digital innovation in healthcare with the aim of ‘fast tracking’ the market of 82 million people which hosts more than 400,000 healthcare professionals.
Starting from the second quarter of 2020, medical apps that are CE-marked as Class 1 and 2a low risk medical devices can apply for ‘fast track’ market entry in Germany.
These changes attempt to put Germany in the lead for digital patient-oriented healthcare globally.
ON THE RECORD
Digital health experts, Jan Bordon and Gabor Kiss from Simon-Kucher & Partners said: “For healthcare companies whose offerings also include digital solutions and apps, this development offers completely new opportunities. This is particularly true for digital health startups, which have little experience and should therefore develop a well-structured approach to this topic. When generating evidence, it’s important to not only focus on the digital healthcare application (DiGA) directory listing requirements set by the Federal Institute for Drugs and Medical Devices (BfArM).”
“Particular attention should be payed to the requirements for price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV), which will take place after the final inclusion of the app in the German DiGa directory. Healthcare companies should not underestimate these.”