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"
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
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).
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)
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.
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.