7th August 2023
Since 2019, digital health applications can be reimbursed in Germany. At the moment, Greek doctors, unlike their German colleagues, cannot yet prescribe apps to their patients. 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, Greece has taken key steps towards the digitalisation of healthcare. Now, there is a pre-pilot project that could lead to emulating the German model.
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.
Greece has a healthy life science start-up scene
So far, around 30 DTx have been introduced into the DiGA Directory in Germany – including some EIT Health-supported 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 effective self-management and lifestyle change.
However, doctors in other European countries, including Greece, cannot yet prescribe these and similar apps to their patients. In Greece, this is especially unfavourable, as digital health plays a vital role in the start-up ecosystem. Up to 80% of life science start-ups in Greece focus on digital health and MedTech, including artificial intelligence (AI), data analytics, web or mobile applications, cloud computing, software, the Internet of Things, and 3D printing.
When can this situation change? To answer the question, EIT Health organised a series of roundtable discussions across Europe, including Greece, in 2021 and 2022. 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
Greece was one of the first countries to introduce e-prescribing. In recent years, there has been significant progress in implementing an electronic patient record (EHR) – although the country falls behind in its implementation, ranked 26th among the EU27, according to a recent study by the Foundation for Economic and Industrial Research. One of the strongest pillars of digital health is telemedicine. Remote consultations are widely applied, among others, to provide services on the Greek islands. Despite such advances in the digital transformation of healthcare, driven by the Ministry of Health and the Hellenic Ministry of Digital Governance, digital health solutions are still not reimbursed in Greece. The exception is teleconsultations, the uptake of which accelerated during the COVID-19 pandemic. The health technology assessment system, put in place in 2018, does not currently address digital health innovations.
Challenges and recommendations
EIT Health recently initiated a dialogue on reimbursable digital therapeutics. One of the initiatives is SymbIASIS – the Capacity Building Programme established by the National Documentation Centre (EKT), the local hub of EIT Health. It aims to connect hospitals and start-ups and could eventually lead to pre-pilot testing and market validation of innovative solutions. In 2022, the Hellenic Ministry of Digital Governance and the Ministry of Health established a dedicated Committee that also aims to explore digital health applications that could pave the way for developing the regulatory landscape. Stakeholders welcome this move since digitalisation and telemedicine services could improve healthcare delivery, especially in remote areas (Greece has 168 inhabited islands).
“We are very glad to see important steps towards the digital transformation of healthcare in the country, even if digital solutions cannot still be prescribed and reimbursed in Greece”, said George Megas, Innovation Consultant and Coordinator of the local EIT Health RIS Hub. “EIT Health contributes to this direction, providing us with tools that can be adapted to the local context and help build the capacities of the Greek ecosystem. Through our hub’s activities, key stakeholders are aware of best practices, new trends and models in digital health, such as DiGA. With our ambitious initiative SymbIASIS we want to help hospitals embrace innovation and start-ups to create products that add real value to healthcare.”
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.’
 EIT Health (2021) ’Flourishing of the Greeek start-up ecosystem’ Available at: https://eithealth.eu/news-article/flourishing-of-the-greek-start-up-ecosystem/ (Accessed: 3 March 2023).
 Ekathimerini.com (2022) ’Greece still ranks low in digital health’, 15 March, Available at: https://www.ekathimerini.com/news/1179739/greece-still-ranks-low-in-digital-health/ (Accessed: 3 March 2023).
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