The statutory German healthcare system is with 72 million insured citizens the largest consistent healthcare system in Europe, and per capita spending even worldwide. It is known for its robustness and above-average effectiveness. Yet, it was almost closed for any form of digital health innovations. The German system still operates without electronic health records or e-medication, and it has only in very limited conditions opened up to digital health applications.
This has changed with the German Parliament’ decision on November 7th to pass the DVG (“Digitale Versorgung Gesetz” / “digital healthcare act”). Among many groundbreaking changes, like the opportunity for statutory health insurances to invest into VC funds to expedite digital health innovations’ market-readiness, the DVG also paves a clear, structured way for digital health applications (in Germany in short “DiGA”) into reimbursement – the so-called Fast Track:
A DiGA need to meet a set of fundamental criteria, including but not limited to data privacy, data security and quality. These criteria will be specified in a regulation by the Federal Health Ministry expected for early 2020 (“Rechtsverordnung”). For reimbursement, a DiGA need to show that it improves Care Delivery (“Positive Versorgungseffekte”).
In many cases, really innovative products are market-ready, but do not have the full scientific evidence, yet. The Fast Track now offers the chance to have a DiGA reimbursed in the first12 months and to use that time window to collect the necessary scientific evidence in a real-world setting. An improvement of Care Delivery consists of either a medical benefit and/or patient related structural or procedural improvements, as known from HTA. Based on the evidence provided when applying after the 12 months conditional listing, the BfArM decides if the DiGA will be permanently reimbursed. In short: Innovations have a fair chance to prove their benefit in a real-world setting.
As soon as the BfArM has approved a DiGA, it can be prescribed by any German physician to any of the 72 million statutory health insured German citizens. During the first twelve months, the DiGA manufacturer can set the DiGA’s price freely, respecting certain requirements.
Our managing director Henrik Matthies had the opportunity to present the DVG at this year’s Frontiers Health conference on Nov 14th in Berlin (pictures above). More than 100 entrepreneurs and healthcare professionals from across Europe used the very lively Q&A to understand the opportunities but also selection criteria in greater detail. Further presentations across Europe are planned for 2020.
>> If you are hosting a major digital health event in Europe in 2020 and would like us to participate on stage, please reach out to us.
More detailed presentations on the DVG, application procedure and criteria:
and the English speaking DVG website of the Federal Ministry of Health.