"We want to attract the best digital health solutions from the market and make them available for the patients insured in the statutory healthcare system. And this has become possible since the Digital Healthcare Act opened the doors for providers also from outside Germany," says Dr Henrik Matthies, managing director of the health innovation hub (hih). The think-tank, established by the Federal Ministry of Health, will host the virtual 'International DiGA Summit' on 16 September 2020.

How to enter one of the largest health markets

Representatives from the German Ministry of Health and the Federal Institute for Drugs and Medical Devices will explain the application process and requirements for the "DiGA Fast Track" – a structured path for digital healthcare solutions to be qualified for reimbursement. Germany's healthcare system is one of the largest in Europe. According to OECD, the spendings per capita reached $6,646 in 2019.

The event will address digital health companies, policymakers, and payer representatives from across the world. Speakers include Jens Spahn, federal minister of health, Dr Gottfried Ludewig, the MoH's head of digitization, Ritu Nalubola, Ph.D., the director of the Europe office in the FDA's office of Global Policy and Strategy, and the president and CEO of HIMSS, Hal Wolf. He will share an international view on how to regulate the market and digital health applications.

Innovations will reach patients faster

Before 'The Act to Improve Healthcare Provision through Digitalisation and Innovation' was adopted in November 2019, there was practically no way for any digital health service or product to access the healthcare system. Now, the federal minister of health, Jens Spahn, wants Germany to become the first country in the world where the statutory health insurance funds reimburse mobile applications.

"The DiGA Fast Track offers an entirely new approach to creating evidence for digital health solutions. Although the digital health application itself must meet fundamental criteria for safety, functionality, quality, data security, and data protection, only little evidence is required in advance. The provider will get 12 months to demonstrate that the application improves healthcare delivery through a medical benefit of structural or procedural improvements for patients," says Dr Matthies in an interview with Healthcare IT News. For many market-ready solutions, already classified as medical products class I or IIa under the European Medical Device Regulation, it's a chance to prove the effectiveness in real-world settings and to be adopted on the market smoothly.

Paving the way to end-users

Since May 2020, developers have been able to apply for DiGA at the Federal Institute for Drugs and Medical Devices (BfArM). The validation process takes about three months. Dr Matthies hopes that by the end of the year, there will be at least 20 digital health solutions accepted and ready to be prescribed by doctors and psychotherapists.

Their providers will also face another exciting challenge: finding the best way to communicate the benefits to physicians and patients. "The DiGA manufacturers will have a lot of space to experiment on how to reach out to end-users and physicians. Besides this, statutory health insurance funds will be allowed to recommend a DiGA or a group of DiGAs to their members. Progressive funds can use it as a USP of their offer," concludes Dr Matthies.

Register for the International DiGA Summit

The online Summit, including the session on 'How to regulate digital health - today and in the future' featuring the president and CEO of HIMSS, Hal Wolf, will take place on 16 September, from 16.00-19.00 (CET). Click here to get your complimentary ticket.

You will learn about what kind of digital solutions qualify for DiGA Fast Track and what the procedure at the Federal Institute of Drugs and Medical Devices looks like. Questions will be addressed during the extensive Q&A round.