Reflecting on a collaborative exchange: Findata hosted delegation from the Netherlands and Belgium to discuss European Health Data Space (EHDS) regulation

With the final version of the European Health Data Space (EHDS) regulation now published, it’s an opportune moment to reflect on a productive exchange that took place earlier this year. Representatives from three countries exchanged insights on their EU-funded projects and discussed opportunities for future collaboration and shared learning.

In late August, Findata had the pleasure of hosting representatives from the Netherlands and Belgium in Helsinki for an in-depth dialogue on the forthcoming EHDS regulation.

Participating organisations included Health-RI, Institute for Public Health and the Environment, Statistics Netherlands, ICTU and Ministry of Health from the Netherlands, as well as the Health Data Agency and Sciensano from Belgium.

The discussions provided a comprehensive overview of the status of each country’s secondary use systems and their respective direct grant initiatives. The goal was to identify ways to learn from each other’s approaches and to prepare together for the EHDS regulation, ultimately enhancing the effectiveness of health data initiatives across Europe.

Status updates and challenges

A key challenge identified was the limited timeframe for EU countries to establish the necessary infrastructure to implement the regulation.

“There are still many unknown variables, and we don’t know the national interpretations,” explained Liesbeth Hak from ICTU.

“It’s like we’re building the ship while we’re sailing,” added Thomas Hellebrand from the Dutch Ministry of Health.

Each country has taken a different approach to address the challenge.

In the Netherlands, a consortium of five organisations has begun exploring technical solutions for the cross-border use of health data. Belgium, by contrast, has first established the Belgian Health Data Agency to facilitate EHDS preparations.

“In terms of the boat metaphor, you [Belgium] have built the boat and are now thinking about building the rowing mechanisms, whereas we [the Dutch] are rowing but without the boat,” joked Hak.

In Finland, Findata has been implementing legislation similar to the EHDS for five years, though further development is needed to achieve full compliance.

“We can safely say that we have both the boat and the oars, but maybe aren’t yet on the shore,” said Johanna Seppänen from Findata.

Strengths and next steps

Both Belgium and the Netherlands have already launched metadata catalogues, which they identified as essential starting points for implementing the EHDS.

“It all starts with the metadata catalogue: you need to know where the data is, what the data is, and how to get that data. Then we need to start optimizing the rest of that whole process,” noted Merlijn van Rijswijk from Health-RI.

Belgium’s next step is determining which authority will grant permits and begin issuing them. Given Belgium’s strong regional governance, it remains to be seen how power will be balanced between the national and regional levels.

Katleen Janssens, Director of the Belgian Health Data Agency (HDA), emphasised the importance of raising awareness about the EHDS among data users and holders, such as hospitals.

“We need to raise awareness about this important upcoming legislation,” Janssens noted.

Belgium has already taken steps in this direction by actively connecting with stakeholders and organising events. They have also launched a Health Data Academy, providing targeted learning materials for different stakeholders.

Looking ahead

The discussions in Helsinki highlighted that while each country has its own methods for preparing for the EHDS regulation, there is significant value in collaboration.

Key topics included:

• The implications of Artificial Intelligence for Health Data Access Bodies (HDABs),
• The impact of broader European Data Strategies, such as the Data Act, Data Governance Act, AI Act, and EHDS, on future operations
• Practical aspects, including managing metadata catalogues, stakeholder engagement, and developing support, training, and capacity-building programs.
• Ensuring security, improving data quality, implementing utility labels, and planning for business continuity and sustainability.

By sharing experiences and ideas, Belgium, the Netherlands, and Finland are taking critical steps towards EHDS readiness. The August meeting established a strong foundation for continued cooperation as the regulation comes into effect.