Digital health act DiGA

A Year With Apps On Prescription In Germany

by Artur Olesch
11 minute read

How has the introduction of the Digital Health Act and certified health apps (DiGA) impacted primary care in Germany? Have patients benefited? Have physicians embraced the new therapy options? The Sidebar speaks to market experts, analyzes the first results, and outlines the big picture of a health system under transition.

The approval of the “Act to Improve Healthcare Provision through Digitalization and Innovation” (Digital Healthcare Act – DVG) on November 7, 2019, paved the way for apps on prescription in a health system with annual spending in excess of 410 billion Euros. It is still a system in its early stage of digitalization. The new law turned out to be a long-awaited spark that fired up a broader shift in healthcare. And even today its meaning goes far beyond a mere legislative amendment.

Technology transforms all industries. Now it’s the healthcare industry’s turn.

Regulations developed during the analog era must be reviewed and updated. The DVG states that “healthcare will be even more data-driven,” while “innovative care structures offer great opportunities for healthcare.”1  Nevertheless, only a few European countries have decided to redesign the legislative and reimbursement framework to get fit for the future. This has changed much since the COVID-19 pandemic exposed the vulnerabilities of the current healthcare architectures.

Implementation of apps on prescription in Germany provides many lessons. On the one hand, it confirms the critical success factors for adoption of novel technologies: political leadership and will, followed by open dialogue with all stakeholders, education, and close collaboration between innovators and healthcare providers. On the other hand, it exposes the pitfalls that can be avoided.

How an app becomes a patient’s trusted digital assistant

Starting from summer 2021, physicians can prescribe a certified DiGA to any of the 73 million statutory-insured German citizens. Among them are solutions developed to support the treatment of mental diseases, diabetes, migraine, insomnia, and obesity.2 To be listed in the DiGA directory—an official register of prescribable and reimbursable digital therapies—an app must pass evaluation by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).3

According to the definition, DiGA is a medical device of risk class I or IIa used by a patient alone or together with a physician. It must support recognizing, monitoring, treating, or alleviating of diseases, injuries, or disabilities; DiGA is not an app that serves primary prevention.

The assessment process takes into account functionality, quality, data protection and security, and interoperability. (See the detailed guide.4) And most importantly — health benefits for patients backed by scientific evidence. Given that clinical trials are expensive and unaffordable, developers can apply for provisional listing in the directory. Under the so-called DiGA Fast-Track, they can deliver the required comparative studies results later, within the trial phase of one year. The manufacturer sets the price of an app but only for the first 12 months. Then it must be negotiated with the National Association of Statutory Health Insurance Funds.

Continue reading below…

Prof. Dr. Med. Jörg F. Debatin, MBA, Chairman of the Health Innovation Hub speaks about how the Digital Health Act and certified health apps (DiGA) have impacted primary care in Germany.

Total benefits higher than the sum of digital applications accepted

Germany’s DiGA Fast-Track is the very first of its kind worldwide to define precise requirements and have a structured process to achieve market access for digital health applications. Twenty apps, as of September 2021, have made it through the certification procedure. In this period, doctors have prescribed 20,000 apps. 75% of all DiGA are preliminarily listed, which confirms that the back door opened through the Fast-Track was much desired.

Most importantly for me, a year after the Federal Institute for Drugs and Medical Devices BfArM opened the DiGA application process, is the mind-shift that happened in the German healthcare system. Today, only a minority questions the necessity of digitalizing the healthcare system,” says Dr. Henrik Matthies.

As the Managing Director of the health innovation hub (HIH), a think tank established by the Federal Ministry of Health under the leadership of Jens Spahn, Dr. Matthies and his team support all national stakeholders by applying the new law in practice.

“In recent months, we have realized how important it is to make use of health data for the benefit of patients and how digital components, such as electronic patient records and e-prescriptions, complete the toolbox for healthcare professionals.”

DiGA has also become an international acronym for digital therapeutics and apps on prescription. “Twenty countries have reached out to us to understand the Fast-Track process as they are currently working on similar legislation,” Dr. Matthies emphasizes. In October 2021, President Emmanuel Macron announced that France would implement the DiGA Fast-Track approach on the French healthcare sector.6

Friedrich Lämmel, the Managing Partner of the Berlin startup Thryve, agrees that digital therapeutics are crucial for tomorrow’s healthcare. They address the challenge of providing longitudinal care for a wide range of non-communicable diseases that pose a huge burden on patients and generate enormous costs for payers.

The regulatory system constrains the level of innovation in healthcare systems, and most of them do not move as quickly as innovators would like. Therefore, enabling digital innovation in a highly regulated environment was an important goal. But, of course, assuming that the necessary improvements will be made on an ongoing basis,” says Lämmel.

By September 2021, twenty out of almost 100 applications were listed. Doctors prescribed apps twenty thousand times. Is this a little or a lot?

While some would praise the successful kick-off of the organizational and legislative framework, and the long-term shift towards high-quality and safe health apps, others focus on inadequate information campaigns, demanding the meeting of eligibility criteria and the missing training for physicians.

It is still a long way to go until the adoption gains momentum. First, physicians have to get used to digital tools, learn how to choose the right app, and then embed it into classical therapies. It’s much more than prescribing an app instead of a pill. There are numerous aspects to be considered: access to technologies, knowledge of how to use them, adherence to digital therapeutics, and trust. Still, not all IT systems in outpatient care have integrated DiGA seamlessly.

Many people—patients and doctors—don’t know yet that we have the possibility to use apps for therapy,” confirms Birgit Bauer, patient expert and advocate. She points out the insufficient information strategy: only well-informed patients, those who actively monitor the news regarding their disease, take advantage of DiGA. “I had to explain to my doctor what DiGA is and how it is used. And I’m not an exception.” According to data published by Tagesspiegel5, 53% of physicians still did not know in February 2021 what DiGA was.

But this can change soon through organic dissemination since there is mainly positive feedback from early adopters.

I see patients who are totally happy when they find out that there is another therapy option for their disease management,” confirms Bauer.

Many citizens living with chronic conditions already use free apps to improve their quality of life and track symptoms. Patients are open-minded in testing and using new things. Still, health benefits rely on the patient’s engagement.

If a patient is not motivated by a doctor to use the tool, there will be no outcomes. We have to focus on how to bring patients and doctors together to work with DiGA. This should be at the forefront of all discussions, instead of technical issues like pricing or reimbursement,” highlights Bauer.

The technology is a means towards outcomes-oriented healthcare

DiGA introduces a profound structural change. Not surprisingly, it will take time for the market to settle down, modify existing culture and deliver the first outcomes. In healthcare, digitalization has its own slow pace. Since it affects people’s health, then quality and safety come first—not the speed of adoption or the technical solution itself.

The establishment of the legal foundations was paradoxically the easiest step. Now follows the lengthy and often frustrating implementation process. Doctors and patients need to learn about the new opportunities and realize the benefits of health apps. Finally, DiGA is only one piece of the puzzle that should fit into the other parts to create a complete digital ecosystem with seamless data exchange, for a coherent patient journey.

“At the moment, DiGA spending is primarily an add-on to all existing healthcare measures. The challenge of steadily increasing healthcare spending seems inherent in the system. However, by breaking down silos, focusing on outcomes and quality, designing healthcare from the perspective of the patient’s journey, I hope that we make better use of the billions spent each year,” concludes Dr. Matthies.

There is another test ahead of DiGA: the first pricing negotiations. Digital applications need regular improvements following new research, data safety requirements and users’ expectations. IT engineers and UX designers constantly introduce new functionalities and modifications that match the patients’ needs, the latest research, or smartphone software updates. It costs time and money. Will the statutory health insurers be ready to reimburse the non-static prices of digital health solutions? What must be done to get the private health insurers on board, which cover 11% of citizens?

Over time it became apparent that the classification of mobile apps as therapies needs rethinking of the regulations in other areas.

For example—marketing in healthcare. In Germany, there are many restrictions when it comes to promoting medical devices and pharmaceuticals. For innovations as young as mobile health apps, this severely limits the ways in which they can be communicated to patients and physicians. Such laws tie the hands of the providers of health apps that could become campaign drivers.

Germany’s DiGA demonstrates that regulations introducing “apps on prescription” have a positive, transformational impact. But, on the other, it also shows that long-term changes need agile improvements, patience and intensive training and promotion. Solid regulation is only the first step.

Sources & References:

  1. https://dserver.bundestag.de/btd/19/134/1913438.pdf
  2. https://diga.bfarm.de/de/verzeichnis
  3. https://www.bfarm.de/EN/Medical-devices/Tasks/Digital-Health-Applications/_node.html
  4. https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf?__blob=publicationFile&v=2
  5. https://background.tagesspiegel.de/gesundheit/warum-aerzte-digas-nicht-verschreiben
  6. https://www.mobihealthnews.com/video/emea/france-adopting-germanys-approach-digital-health-apps

 

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