OBJECTIVES: In 2018 Germany were ranked 17^th out of 18 countries for their level of digitisation of healthcare delivery, as reported by the SmartHealthSystems study. Just 2 years later the German government introduced the Digital Healthcare Act, stimulating the implementation of the DiGA system (Digitale Gesundheitsanwendung), in combination with use of electronic health records and e-prescribing. These changes have propelled the German method of leveraging Digital Health Technologies (DHTs) to the forefront of European healthcare digitization, such that several other European countries are modelling their approach on Germany’s methodology. Here, we explore the key success factors of the German program, and how other EU markets are adapting their national frameworks based on this.

METHODS: We analysed the changes brought in by the Digital Healthcare Act, and the impact this had on the use of DHTs, compared to DHT use prior to introduction of the act. Through scrutiny of governmental policy we also assessed how other EU markets structured and implemented their DHT assessment systems to compare similarities and differences between their and Germany’s frameworks.

RESULTS: The Germany DiGA system has been replicated, or modeled upon, by several EU countries, including France with their PECAN model, Belgium, Spain and several of the Nordics markets. Small differences exist between systems, such as the classes of DHTs eligible for DiGA vs. PECAN. There are also discussions to utilize the German DiGA approach towards harmonizing market access for reimbursable medical apps across Europe.

CONCLUSIONS: Germany’s DiGA fast track process for DHTs is considered best-in-class and well suited for European health systems. This required a substantial change in legislation, but decisive and focused action has resulted in 1000’s of patients now benefiting from using DHTs, as well as allowing for high levels of innovation.