What makes the events of the health innovation hub compelling, is the fact that our speakers are often precisely the policy makers who wrote the laws beforehand and/or the public officials in charge of their implementiation. It was a great honor to have the Federal Minister of Health, Jens Spahn opening the Summit and to listen to a keynote by Prof. Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM). Afterwards, representatives from the Federal Ministry of Health and BfArM highlighted the motivation behind the ‘DiGA Fast Track’ and went more into detail by running through the process.
The Fast Track defines requirements for qualified digital health applications (abbreviated in German as ‘DiGA’) to be listed in the DiGA registry as well as the subsequent reimbursement of these digital health applications. Once listed, any German physician or psychiatrist can prescribe a DiGA to any of the 73 million statutory insured German citizens. The first BfArM-listed DiGA is expected to hit the market in the coming days.
Links to Summit video & slides
- The video recording of the 3h Summit can be found in the hih Youtube channel here, a quick guide to the event is listed in the video descriptor
- The hih moderation & content slides of the event can be found here
- Slides of the Federal Ministry of Health are here
- and here are the slides of BfArM
If you are new to the DiGA Fast Track, the ‘How to DiGA’ BfArM session with Dr. Wiebke Löbker and Dr. Wolfgang Lauer is a great starting point. The same BfArM team wrote an
Which is the best possible document to inform you about the DiGA Fast Track in great detail, understand all requirements & processes and get first hand information from the perspective of those responsible for executing the application process. Also check out their slides (see link above) which walk you through the free-of-charge DiGA Guide. We strongly recommend you read this PDF when you are deciding whether or not to apply for the Fast Track!
Many questions arise around the topics of data privacy / data security when applying for the Fast Track. Germany is known for its very strict data regulation, and this is even more true for health data. And as the European court recently rejected the EU-US privacy shield, non-EU DiGA manufacturers as well as EU DiGA manufacturers who use services like AWS face new requirements.
- Check out the “How to DiGA” sessions by hih’s data privacy expert Dr. Philipp Kircher to get an up-to-date overview.
The second most discussed topic is around the nature of the scientific evidence required to support an individual DiGA’s claim. Claims can either be of medical benefit and/or ‘structural and procedural effects’. The latter represents a completely new category of health care benefit and dimension and is centered around how a DiGA can improve the patient’s daily life.
- Check out hih’s HTA expert Jan Broenneke’s session to learn more about the status quo.
Additionally, you should understand how the prescription and billing process work in order to prepare your DiGA for these requirements. If your DiGA is not a browser-based service but a native app, a few additional details are important to consider. And finally, put yourself into a physician’s shoes and think to what extent your DiGA makes their work with the patient easier or better. Because if a physician / psychiatrist is not convinced of the value of a DiGA they may not prescribe it.
- In the final“How to DiGA” session, hih’s all purpose expert Julia Hagen outlines the prescription process while co-host and hih’s Managing Director Dr. Henrik Matthies explains what to look out for before submitting your native app to the App-/Play Store, as well as how physicians and psychiatrists may view the DiGA Fast Track.
Western health systems are treating medical devices and digital health applications very differently, but many of them are open to digital health and work on their systems to ease DiGA & friends market access. In our Panel discussion “How to regulate the digital health future – DiGA and beyond”, moderated by hih’s Chairman and digital health ambassador Prof. Jörg Debatin, Dr. Rita Nalubola (Director of the FDA Europe office) outlined US-regulatory efforts around digital health, while Dr. Päivi Sillanaukee (Health ambassador of the Ministry of Foreign Affairs in Finland) showed how her country managed to grant research large-scale access to the nation’s digital health data within the GDPR framework. Hal Wolf, President & CEO of HIMSS, debated the role of the incumbent medtech-IT world vis-a-vis digital health and to the extent to which international interoperability formats as well as open interfaces bring us closer to a true health ecosystem. Dr. Gottfried Ludewig, the mastermind behind Germany’s DiGA Fast Track in the German Ministry of Health as well as many other digital health reforms explained his motivation and provided his outlook on which parts of the German healthcare system will be innovated in next.
If you are considering applying for the Fast Track, make sure to read BfArM’s DiGA Guide (see above, good introduction also on their DiGA-website).
Many requirements such as the prescription process or the reimbursement framework will be discussed between the leading DiGA-manufacturing organisations on the one side and the GKV-SV (National Association of the Statutory Health Insurance Funds) on the other side. If you want your voice heard in these negotiations, it may make sense to join one of the manufacturers organizations. Below is a list of the largest organizations, some of which also have English-language content:
– BiM Bundesverband Internetmedizin
– Bitkom e.V.
– Spitzenverband Digitale Gesundheitsversorgung e.V.
– VdigG Verband digitale Gesundheit
– VDGH Verband der Diagnostica-Industrie e.V.
– ZVEI Zentralverband Elektrotechnik- und Elektronikindustrie
If you are still at an early stage in your product development and market approach and want more background on how to setup a digital health company in the German market, which alternatives to the Fast Track exist, which regulations (beyond the Fast Track) you have to comply with, and how the German health systems works, hih’s DiGA experts and team members wrote a handbook “DiGA Vademecum” which will be published early October 2020. For now the handbook will only be available in German, but an English version is expected soon.
Due to time constraints, we were not able to answer all questions posted on Slido during the event in the Q&A session. We will update this blogpost over the coming days with the answers from the Federal Ministry of Health, BfArM and hih – but wanted to provide you with video, slides and summary without further delay.
Feedback – next events
The International DiGA Summit was hih’s first English-speaking conference and we are open for your feedback. Please send us your thoughts to firstname.lastname@example.org, Re: “International DiGA Summit”.
The hih hosts events around all health digitization topics. In addition the DiGA Fast Track, the German health system will introduce electronic patient records starting on January 1st 2021, followed by electronic prescriping in Summer 2021. Furthermore, the German parliament just passed a EUR 4,3 bn. program to support the digitization of German hospitals. All of these topics will be explained and discussed by the hih team in the near future. Most events will be in German, but we are already planning the next English-speaking DiGA format once we have gathered learnings and feedback from this first experience and once the pricing framework has been negotiated and established. We look forward to staying in touch with you!