R2G Report: Entering the German market with a digital health solution

A white paper from Research2Guidance finds that gaining DiGA approval alone does not ensure the adoption and success of healthcare apps.
By Tammy Lovell
12:18 pm

R2R managing director, Ralf Jahns

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 Digital Healthcare Act mean that approved CE-marked  apps can be prescribed by doctors and reimbursed through German health insurance.

To gain DiGA approval, providers must prove to the German Federal Institute for Drugs and Medical Devices (BfArM), that their apps can improve patient care and meet specified criteria.

However, R2G’s report says that attaining DiGA status alone is not enough to ensure success in the German market and providers must also develop a comprehensive market entry strategy to drive adoption. It recommends measures such as providing high quality clinical evidence, selecting distribution channels and planning provider outreach.

Figures from R2G’s market analysis show that although apps see an immediate growth in downloads after DiGA listing, this growth does not appear to be sustained in the mid-term. 

R2G predicts the direct impact of the DiGA process will be limited for at least two

years by the number of solutions accepted by the regulatory institutions and slow adoption among healthcare providers.


As the largest economy in Europe, Germany has long seemed an attractive market for digital health startups around the world.

Around 73 million people are under Germany’s statutory insurance system, representing 90% of the population. However, tough regulations have limited foreign investment and growth. 


To date, 68 solutions have been submitted to the BfARM for DiGA status, of which 12 have been approved.

Most of the approved solutions focus on mental health, such as the Deprexis app which is used to treat depression.  Only two applications have been rejected so far, while the rest remain under review. 

Meanwhile, Health Innovation Hub chairman Jörg Debatin recently told MobiHealthNews how Germany’s digital infrastructure and interoperability have helped empower its patients. 


Ralf-Gordon Jahns, managing director of R2G, said: "The German healthcare market offers significant business opportunities for digital health startups from around the world. This is even more true in light of the recent regulatory changes in favour of digital solutions. 

“Most notable from them is the DiGA Fast Track process, which came into effect in 2020. This has enabled health apps to be prescribed and reimbursed by statutory health insurances. Nevertheless, major challenges exist including price and business model definition, HCP education, distribution channels that match with startup resources and efficient evidence creation.

“The R2G whitepaper explains market entry opportunities and challenges in the German healthcare market and provides tips for an efficient market entry."


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