This year, Frontiers has been a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition has been hybrid, combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, the USA, Switzerland and more.

It has been dedicated to digital health innovation in the context of the “new normal”, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation and ecosystem development.

You can read the full live coverage on the pharmaphorum dedicated pages: Day 1 – Day 2

By Laura Richter and Tobias Silberzahn, McKinsey & Company

In the past years, German politicians have put digitization of the nation’s healthcare system at the top of their agendas. During this journey, one question has come up repeatedly: How much progress has been made since the Bertelsmann Foundation ranked Germany 16^th out of the 17 health systems assessed in its Digital Health Index in 2018? To generate a shared basis for discussion, an objective overview of the current situation was needed.

That overview has now been created with the new eHealth Monitor. Using 30 indicators, the Monitor allows for the exploration of digital technological maturity and infrastructure in German healthcare facilities; a review of the services and products available from providers, pharmacies, and health insurers; analysis on patients’ willingness to engage with digital health services; and evaluation of e-health-related benefits and evidence of those benefits as reflected in the latest published research. Furthermore, the eHealth app barometer measures the success of health apps based on total downloads.

Indicators are supplemented by exciting perspectives from guest contributors, which include the German Ministry of Health, the Federal Association of Managed Care (BMC), the Bertelsmann Foundation, and CEOs from three health technology companies. Also included: The patient voice and the physician perspective.

Join Dr. Tobias Silberzahn at Frontiers Health 2020

Legislative agenda

Over the past two years, Germany has made considerable headway in building the “foundation” for digitization via its legislative agenda. Particularly where the creation of regulated market access for digital health applications (DiGAs) is concerned, Germany is taking the lead internationally. It now needs to maintain the speed of the transformation process. Furthermore, it needs to catch up with those countries that have already finished creating a foundation for digital healthcare and that are now hard at work creating measurable benefits for patients, healthcare professionals, and other stakeholders.

Key insights

In recent years, Germany has progressed on the foundational elements of healthcare digitization: Progress was achieved in the areas of electronic health records, e-prescriptions, and DiGAs. Yet there are still many areas where digitization needs to be accelerated as quickly as possible: Many medical facilities are still operating in an “analog world”.

In 2019, for example, 93 percent of doctors still relied on paper-based means for communicating with hospitals. Options for ordering prescriptions via a website or for viewing documents online were available in just 15 percent of outpatient practices, and 59 percent of physicians offered their patients no digital services whatsoever^[1].

In contrast, patients are very open to digital solutions: One in three respondents of an online survey said that they already schedule doctor’s visits online, and two out of three Germans welcome the introduction of electronic health records and e-prescriptions ─ and this also held true for over 60 percent of respondents in the generation of individuals aged 65-years and higher^[2].

In the context of the COVID-19 pandemic, progress has been made in telemedicine service offers over the past 2 years: A survey of physicians conducted in the spring of 2020 showed that 52 percent of all outpatient doctors offered video consultations. That figure was just 2 percent at the end of 2017^[3].

Evidence of benefits

The eHealth Monitor also delivers fresh insights on the benefits of e-health solutions in Germany. An analysis based on the PubMed search engine shows that from 2000 to 2020, 158 articles were published on e-health solutions for Germany.

More than 80 percent of German medical research publications have confirmed positive benefits from e-health solutions, and these effects are most noticeable in improvements to patients’ health (found in nearly 80 percent of the studies analyzed), and in the form of greater cost efficiency and time savings^[4].

Of course, due to Germany’s new approval and reimbursement process for DiGAs, the number of published articles is likely to increase in the future, as e-health service providers are now required to scientifically prove the benefits of their solutions. More evidence is crucial and will be a success factor in the further implementation of e-health solutions.

hih is a think-tank of the Federal Ministry of Health – an initiative launched by the German government in 2019 as an answer to the country’s digitalization struggles. hih stayed a bit behind the curtain but the agency is in fact working directly on the implementation of Germany’s Digital Healthcare Act (DVG) with Henrik being one of its main drivers. Apart from the Digital Care Act, hih also works on many other projects in the field such as the electronic patient record, the digitization of hospitals and the digitization of Germany’s public health efforts during Covid19.

You can read more about Germany’s Digital Health Act and the “Fast Track” procedure and learn the opinions of the startups-participants in our recent interview.

– Henrik, let’s start with an overview of the recent International DiGA Summit – the event held by hih in September 2020 to discuss the Digital Care Act. What was the purpose of the event and what are your impressions of the Summit that counted with the presence of the Federal Minister of Health?

We have planned to host such an international event in English for a very long time as we realized that opening the German market to digitization means that we shall also attract the brightest solutions from all over the world. Such an approach is absolutely new for the German healthcare system which so far has been very closed, very German, very rigid and complex in structure. The ‘Fast Track’ is, vice versa, a transparent, structured and the quickest possible path for digital health solutions (in German in short ‘DiGA’) to enter the system.

To be honest, the ‘DiGA Fast Track’ is very selfish: we want to have the best possible healthcare in Germany. And to get the best possible healthcare, we need to have the best possible solutions which exist around the world. The Summit was held to make sure that everyone understands how the process works and that we are serious in attracting the global health audience. In the past I was a co-founder of two larger tech companies, hence my interest was also to make the Summit founder-oriented and explain what the law implicates for DiGA manufacturers.

In terms of reach, we were quite overwhelmed: more than 1500 visitors from more than 40 countries tuned in. It was a very positive surprise to us that a government agency is able to generate such a reach in order to explain a single law.

– During the Summit you had a live feed with the questions from the audience. Were there any unexpected questions?

Curiously enough, a question raised many times was about how much will be charged when consulting about the DVG and ‘Fast track’. Well, the BfArM guide – the best document to get started and understand the Fast Track process and criteria – is a simple PDF download, and it’s, of course, for free.

A big learning for us was that we have to make a better job in educating the non-German companies on how the German healthcare system works. We didn’t hold a section dedicated to the German healthcare system that was initially considered and I think this section would have addressed or even prevented many of the actually asked questions.

– Indeed, each single national healthcare system sets up a big barrier to entry.

Yes, one of the challenges for a digital health startup or company is the complete diversity of the healthcare ecosystems even inside the EU. All of them are so different that startups need a lot of adaptation. And my next goal would be to get a more aligned structure across Europe: if you once succeed in entering one market and comply with the regulations, say, in Finland, it shouldn’t be too much of a hassle to also expand to Germany, France or Belgium and vice versa. But we are not there yet.

At the DiGA Summit we had many policy makers also from other nations and we stimulated a lot of knowhow exchange. We realized we need to make sure that before other countries start to implement anything, they shall know our learnings and the pros and cons of our framework. Such experience transfer will help to move towards more harmonization within the healthcare systems across the European Union.

– In the event’s feed I saw some critical comments and questions regarding the ‘not digitally-friendly’ prescription procedure for the ‘Fast Track’ startups (right now the prescription procedure for the digital health apps is paper-based and also requires the patient to call his insurance company to get the activation code – editorial remark).

You can imagine that implementing the DVG required the interaction with a lot of regulatory framework, infrastructure and processes that are already in place. We couldn’t invent a completely new healthcare system from scratch. There are many requirements for the GPs that are already in practice and these requirements also touch health data privacy and security issues, its storage, access and handling. Within this given setup we had to come up with a smart idea on how to prescribe the digital solutions like ‘tomorrow‘ – because the 9 months that we had to set everything up equals in healthcare thinking ‘tomorrow‘. And we wanted to make sure that any physician and any of more than 100 statutory health insurance fund could use the prescription process from day one as well as 150 000 physicians and psychotherapists.

– To sum up, how many startups are currently in the process of applying to operate under the Digital Healthcare Act?

There are more than 20 companies already in the Fast Track application process and more than 70 had a consultation with BfArM – that’s usually the step before you decide whether to apply or not. A very promising indicator towards market acceptance is the broad range of solutions that we are going to have, from therapeutics to mental health and chronic diseases. For the first time ever, many physicians in Germany will deal with DiGA and realiz how they can actually benefit from it. Equally, millions of patients will finally have something additional to their usual therapy, something which goes beyond medication. The digital solutions will accompany them in their pocket and become a part of the patients’ everyday life.

keep an eye on our page because soon we will release also the second part of the interview with even more exclusive news about European venture capital market and digital health. Stay tuned!

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

This free pharmaphorum webinar saw our expert panel discuss:

• Growth and investment in digital health, the digital therapeutics (DTx) spectrum and where pharma is active in this space
• What is a DTx, how the digital health landscape is expanding and what are the benefits of DTx
• The value of DTx for patients, with some case studies for patients and HCPs (and pharma) and a look at the reimbursement of DTx – what to address and what counts as ‘value’
• The anatomy of a DTx, the customer experience component, and then a look at the ‘go-to-market’ part of these solutions

Roberto Ascione, Healthware CEO, has joined the expert panel along with Megan Coder, Executive Director at Digital Therapeutics Alliance, Pierre Leurent, CEO and founder at Voluntis, Marc Sluijs, Founder at DigitalHealth.Network and Dominic Tyer, Creative Director at pharmaphorum and moderator of the panel.

More info about the free webinar here

2 days of conference activities to dive into guiding themes inspired to healthcare trends and innovation topics: Breakthrough Innovations, Scientific and Medical Validation, Reimbursement and Business Models, Strategic Partnerships, Digital Therapies, Design for Health Transformation, Funding, M&A, path to value, Health Insurance Innovation.

2017 in numbers

500 delegates, 30 countries, 74 presentations, 130 startups and over 70 investors.

Book your seat and join the conversation!