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The German Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) is a major milestone on the path to the digitalisation of the German healthcare system. It allows the German Federal Government to break new ground and set new national and international standards. And at the same time, the DVG is creating entirely new opportunities to improve the scalability of proven and effective digital medical products. This development is fully in line with Emperras strategic focus.

What does the DVG entail?

According to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the DVG facilitates “apps on prescription”[1]. This means that it is now finally possible for doctors to issue prescriptions for digital medical products such as apps. Or in other words: Digital healthcare applications (Digitale Gesundheitsanwendungen, DiGA) are now available on prescription. The honorary title DiGA designates applications that verifiably improve patient care. This includes, for example, apps with a clinical benefit that have been substantiated in studies and can therefore be flawlessly integrated in treatment procedures.

What are the effects of the DVG?

With the passing of the DVG, around 73 million individuals insured through public health insurance can now claim reimbursable DiGA-based treatment concepts. This is the first time that health insurance providers have provided comprehensive and regulated cost absorption for DiGAs. Previously, only bypass solutions had existed and were offered only by individual providers e.g. in the form of selective contracts. But now, thanks to a mandatory and comprehensive reimbursement policy, the DVG makes it possible for innovators in digital medical products to achieve their well-deserved return on investment.

How does a digital medical product become a reimbursable DiGA?

Since June 2020, businesses have been able to apply to the BfArM for inclusion of their digital medical product in the official DiGA catalogue. The BfArM has strict criteria to determine which products will be classified as reimbursable DiGA. To achieve this objective, manufacturers of said products must adhere to the BfArM guidelines, the DVG as well as the normative and statutory requirements for recognition of medical products.

The main criteria of DiGAs include, among other things:

  • classification as medical devices of class I or IIa,
  • having a conclusive data protection concept,
  • substantiation of their medical benefit or treatment benefit through scientific studies. Applications that are only lacking the large-scale study may be granted temporary inclusion in the DiGA catalogue (duration: 1 year). However, the required comparative study must be conducted within this year.

What is Emperra’s status with regard to reimbursable DiGAs?

According to external experts, there are sufficient studies to warrant the inclusion of Emperra’s ESYSTA app in combination with the ESYSTA portal in the DiGA catalogue; the respective application was submitted as early as possible. At the moment, Emperra is one of the first 15 applicants in Germany that are currently undergoing the verification process.

Emperra consulted external experts in the course of the application process who diligently assessed the viability of ESYSTA as a DiGA. Their verdicts were extremely positive, which is why Emperra is confident that the product will be listed as a permanent DiGA in the near future.

What does the DVG mean for Emperra?

If Emperra’s digital medical products were to be included in the DiGA catalogue, this would result in:

  1. Improved scalability: For Emperra, comprehensive reimbursement would improve the scalability of the purely digital ESYSTA products. Whether 10,000 or 100,000 people use the ESYSTA applications has only a minor effect on the respective investments and overheads.
  2. Improved initial B2C marketing-situation: Due to the DVG, all patients now have a legal right to claim DiGAs as well as reimbursement thereof by their health insurance provider. As a result, patients have now been granted additional decision-making authority. This means that Emperra’s patient-directed marketing measures will potentially gain in momentum. An auxiliary aspect – that additionally benefits successful treatment outcomes – is that, as the decision-makers, patients might potentially develop a greater sense of responsibility for their own care.

What doesn’t the DVG mean for Emperra?

As important as the consolidation of a patient’s decision-making authority is, Emperra’s holistic and integrative approach as embodied by the ESYSTA products remains focused on the integration of all stakeholders in the treatment process. These are the doctors and diabetologists, the patients and health insurance providers as well as, where applicable, the care facilities of diabetes patients and, last but not least, their support systems. Successful B2C marketing will – as ever – not overlook the importance of B2B marketing.

Conclusion

The degree of innovation in the DVG and of DiGAs is formidable. Germany is not only the first country in the world to systematically assess the verifiable benefits of healthcare apps but also the first country in which health insurance providers will fund apps with a respective added value. This pioneering work is a credit to all those involved, and Emperra is extremely proud to have ESYSTA at the forefront of this revolution.

 

Invest in Emperra’s leading edge today

Do you also want to financially profit from the new opportunities created by the DVG? Then invest in Emperra and its app – that is currently undergoing the DiGA recognition procedure –  today on the digital venture capital platform Aescuvest.

 

[1] https://www.bfarm.de/DE/Medizinprodukte/DVG/_node.html