18th May 2023
Since 2019, digital health applications can be reimbursed in Germany. At the moment, Hungarian doctors, unlike their German colleagues, cannot yet prescribe apps to their patients. It is because there is no system in place to distinguish safe and effective digital therapeutics from the thousands of wellness and health apps available on the market.
According to experts who participated in a roundtable discussion organised by EIT Health, part of the European Institute of Innovation and Technology (EIT), a body of the European Union, Hungary has taken key steps towards the digitalisation of healthcare in recent years but still needs to overcome several obstacles before it can emulate the German model. However, doctors in other European countries, including Hungary, cannot yet prescribe these and similar apps to their patients. As a result, Hungarian healthcare start-ups tend to target foreign markets like Germany and France if they would like to have reimbursement for their digital solutions.
The German experiment
In 2019, the German Digital Healthcare Act introduced a new approach to market access for reliable and safe digital health applications. The legislation aimed to select digital solutions with proven clinical benefits from the 400,000+ health and wellness apps. Since then, digital therapies have become a new form of medicine called digital therapeutics (DTx). DTx can now be prescribed by German doctors and reimbursed by public payers, similarly to traditional medications and treatments.
DTx must undergo a thorough investigation before they can be approved as digital health applications (Digitale Gesundheitsanwendungen, DiGA). If they meet the requirements related to safety, functionality, quality, data protection, data security and interoperability, they are eligible for regulatory review and entry into a DiGA Directory maintained by the German Federal Agency for Drugs and Medical Devices. The positive care effects of a DTx can be demonstrated in two ways: in a 12-month ‘fast-track’ or if a developer delivers evidence, for example, clinical trial results. When all the criteria are met, the digital solution enters the healthcare system and can be reimbursed by all of Germany’s statutory health insurers.
Hungarian health start-ups must target foreign markets first
So far, around 30 DTx have been introduced into the DiGA Directory in Germany – including some innovations from Central, Eastern and Southern Europe. One example is a product called re.flex, developed by Romanian start-up Kineto Tech Rehab. Another example is Vitadio, a digital application developed by a Czech start-up for people with type 2 diabetes, supporting them in self-management and lifestyle change.
However, doctors in other European countries, including Hungary, cannot yet prescribe these and similar apps to their patients. As a result, Hungarian healthcare start-ups tend to target foreign markets like Germany and France for reimbursement of their digital solutions. This significantly undermines Hungary’s digital health innovation ecosystem. They include several success stories that have received significant support from EIT Health in recent years, such as the Fetal Health device and application, or InSimu, the Virtual Patient Simulator and Assessment Platform. This situation also creates a gap in accessibility to digital health innovations for patients of both the state and private healthcare providers.
When can this situation change? To answer the question, EIT Health organised a series of roundtable discussions across Europe, including Hungary, in 2022 and 2023. The events brought together experts and stakeholders from healthcare, medical device regulatory affairs, academia, and business to discuss the German model and its potential to inspire digital health regulatory frameworks in different EU countries.
Signs of progress in recent years
Several necessary steps have been taken around digital healthcare in recent years, partly catalysed by the lockdowns due to the COVID-19 pandemic. The National eHealth Infrastructure (EESZT) was launched in 2017 as a central e-health system facilitating data exchange between providers, healthcare professionals, pharmacies, and patients. EESZT quickly became a popular platform for sharing data like e-prescriptions or electronic health records.
The digitalisation of the health sector made it possible to guarantee the continuity of medical services for patients during the pandemic. Among European countries, Hungary saw one of the biggest increases (+50%) in the share of remote consultations with general practitioners between June/July 2020 and February/March 2021. Besides, the national payer – Health Insurance Fund – can reimburse telecare services if they meet specific requirements. During the pandemic, the Hungarian government and healthcare stakeholders also set up a Data Team, which has had significant results in easing the bad consequences of the pandemic. The Data Team has used connected databases, AI and Big Data-based algorithms to predict and support decisions.
Challenges and recommendations
Despite the progress, there is currently no official system in place to approve digital therapeutics for medical use. In Hungary, devices are regulated by the National Institute of Pharmacy and Nutrition, but to date, it has not been extended or updated to include digital health solutions. Thus, digital therapeutics remain unregulated, and there is no division between safe and reliable digital health solutions with demonstrated clinical benefits for patients and the thousands of wellness apps on the market.
“There are several prerequisites of digital health solution usage in a country – at first, we have to focus on education and attitude fine-tuning of patients and physicians”, said Zsolt Bubori, Ecosystem Lead for Hungary at EIT Health InnoStars, following the roundtable discussion. “After establishing and developing our social capital and culture regarding digital health, we can start creating structures, processes and tools. When we have these factors, finance and funding will be smart by definition, and we will see digital health as a high-tech industry that supports economic growth and success.”
During the roundtable, several recommendations were put forward by the experts, including the introduction of a certification system for “trusted apps” and the development of a new framework for market access for DTx jointly with the National Institute of Pharmacy and Nutrition and the State Department of Health. There is also a need to establish hubs in the national healthcare system where MedTech companies could cooperate with healthcare providers and academic centres on solutions with scientifically demonstrated benefits.
The EIT Health report offering pan-European overview on the state of the digital health and care transformation in the individual Member States can be found at: ‘Digital Medical Devices: Paths to European Harmonisation.’
 OECD/European Observatory on Health Systems and Policies (2021) ’State of Health in the EU, Hungary: Country Health Profile 2021’ Available at: https://health.ec.europa.eu/system/files/2021-12/2021_chp_hu_english.pdf (Accessed: 3 March 2023)