Towards harmonised EU Landscape for Digital Health: Summary of the roundtable discussions in selected InnoStars countries – a new study

In 2022 InnoStars organised roundtable discussions about the directions of the development of digital therapeutics and possible reimbursement models. The report summarises key takeaways from discussions in Italy, Estonia, Romania, Greece, Hungary and Portugal. EIT Health InnoStars organised them under the umbrella of Morning Health Talks.

A new element of the European digital health

In 2019, the German Digital Healthcare Act (Digitale Versorgung-Gesetz) introduced a new approach to market access for reliable and safe digital health apps. The legislation aimed to separate digital health solutions with proven clinical benefits for patients from over 400 000 other health and wellness apps available on the market[1]. Since then, digital therapies have become a new form of medicine called digital therapeutics (DTx). DTx can be prescribed by doctors and reimbursed by public payers.

Other European countries look to the same direction

The German fast-track system triggered interest in Europe. Already several European countries are considering similar frameworks to allow for the wide adoption of digital health solutions within their national healthcare systems. France is the most forthcoming – the DiGA-based model is expected to be launched in early 2023.

Meanwhile, the EU is advocating for the implementation of its Data Strategy. The last building block – the EU Data Act – was presented on 23 February 2022 and is expected to play a critical role in the digital transformation in line with the 2030 digital objectives. Another driver for DTx could be the European Health Data Space (EHDS)[2], which will give the developers better access to data needed to train algorithms applied in AI-driven health apps.

Conclusions

The study by InnoStars in selected Central, Eastern and Southern Europe countries aimed to map the landscape of the national digital health ecosystems and identify current capabilities for introducing a shared European approach to DTx.

It includes a deep dive into the current state of digitisation and DTx readiness, measured by the development of digital infrastructure, the implementation of essential e-health solutions, the degree of digital literacy, acceptance of digital health tools among healthcare professionals and citizens, and regulatory framework.

The recommendations for the acceleration of DTx in the EU include:

• EU needs a vision for a common DTx single market and must take steps toward harmonising national approaches in this field.
• A significant obstacle to the development of DTx is the financial limitations of start-ups in generating evidence, such as in the process of randomised clinical trials using real-world data. However, special funding programmes in this area could spur DTx development in Europe.
• Unless a pan-European approach to DTx is established, there is a risk of creating innovation centres in countries with favourable regulatory frameworks and marginalising countries that are lagging. The result is a migration of start-ups, as is happening in countries with low rates of innovation. It also includes focusing more on digitalisation in the EU Member States that fall behind in digital infrastructure, (digital) health literacy and skills to avoid digital gaps in the EU.
• EIT Health has the competencies and network to lead the dialogue on DTx between different EU countries and stimulate the exchange of know-how to develop the best models adjusted to national healthcare landscapes.

The report is available here.

[1] https://www.economist.com/technology-quarterly/2022/05/02/apps-interpreting-data-from-wearable-devices-are-helping-people-to-live-better

[2] The European Commission’s proposal for a Regulation on the European Health Data Space was published on 3 May 2022.