Germany’s push towards Healthcare 4.0 – A guide to the new fast-track pathway to reimbursement for digital health apps

The Internet of Medical Things (IoMT) continues to be one of the hottest topics in the global life sciences and healthcare industry. The new German Digital Healthcare Act (DHA – DigitaleVersorgungGesetz/DVG) entered into force on December 19, 2019. This legislation massively pushes Germany towards Healthcare 4.0 and may usher in an era of great opportunities: not only for traditional players in the life sciences and healthcare market, but also for newcomers to this sector, including tech giants, tech startups and data-driven enterprises. Among many other groundbreaking initiatives to accelerate the digital transformation, innovation and agility of the German healthcare system, the DHA enables any physician or psychotherapist in Germany to prescribe Digital Health Applications (DHApps – digitale Gesundheitsanwendungen) to the approximately 90% of the population who are covered by the country’s Statutory Health Insurance (SHI – gesetzliche Krankenversicherung/GKV). Makers of DH-Apps are being given superfast access to the highly lucrative German healthcare reimbursement system.

Most notably, for a period of up to 12 months the makers of DH-Apps have the chance to additionally test their products and gather real-world scientific data on their benefits. Provisionally, the SHIs will also be required to fully reimburse the selling price of DH-Apps, which their makers may freely set at the start, of course provided that the products already fulfill the other key criteria, such as safety, functionality, quality, data privacy and data security. Based on the scientific evidence gathered, after the 12-month testing period, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte/BfArM) will take the decision to list a specific DH-App for permanent reimbursement. In this context, the final fixed price will also be negotiated with its maker. With this strategy, according to the German Federal Ministry of Health (Bundesministerium für Gesundheit), Germany will become the first country in the world to put an end to the “Wild West” that now exists in some parts of the digital health industry, with the actual health benefits of such applications for patients and whether or not they comply with data protection standards often being unclear.

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