Much remains to be done for the European Health Data Space

Under the Danish Council Presidency, government representatives, EU representatives, industry, and international organizations discussed the European Health Data Space (EHDS) in Copenhagen, which has been in force since March. The EHDS is intended to enable the secure and standardized exchange of health data – for example from the electronic patient file or the 400 medical registers – in the European Union and improve research and care. For example, anyone traveling to another EU country should in the future have access to all data relevant to their treatment there. The topics of trust and security, as well as the ongoing public comment phase for the corresponding guidelines and specifications, were central to the discussion.

The Technology and Methods Platform for Networked Medical Research (TMF) recently organized an extensive series of workshops as part of the public consultation. Guidelines and technical specifications for the secondary use of health data have already been drawn up on behalf of the EU Commission – This is one of a total of three waves. They define the conditions under which researchers, companies, and authorities will be allowed to use European health data in the future. These include, in particular, guidelines on data categories and permitted purposes of use, on the tasks and structures of national data access points, and on requirements for security, interoperability, and governance. This will later serve as the basis for the application of the EHDS.

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"We regard health data as a resource that, if handled responsibly and securely, can transform our healthcare system," said Dorte Bech Vizard from the Danish Ministry of Health. The EHDS could ensure growth and secure care. However, she also warned that it would take a long time to build and maintain trust. "Let's get this right so that EU citizens can trust their healthcare systems, trust that medicines will be available when they are needed and that innovation will reach them without unnecessary delay."

"This is the crucial phase in which we jointly determine how data will strengthen Europe's healthcare systems," explained Marco Marcella, who is responsible for digitalization and "EU4Health" at the European Commission. The infrastructure is to be established by 2029. The new legal framework will then come fully into force. Marcella also spoke about the ongoing public consultation, which he described as fully transparent. He called on participants to get actively involved. "We will only succeed if we build this system together." If the EHDS is set up correctly, "Europe can not only modernize its healthcare systems, but also create a global model that inspires others."

At the event, there will be an opportunity to speak with the authors of the eleven documents that have been released for comment. Markus Kalliola, Programme Director at the Finnish Innovation Fund Sitra and part of the coordination team of the TEHDAS project, pointed this out. In the future, all countries are to publish metadata catalogs that researchers can use to search for data. He emphasized that researchers will not receive the data, but will only be able to access it within secure execution environments. They should then only receive and publish the study results. However, there is still a lot to do before this is achieved.

Sandy Vance, representative of the Vulcan project, which aims to improve data exchange, explained how technical interoperability and common standards support the implementation of the EHDS:"HL7 FHIR enables seamless, secure communication between different healthcare systems." HL7 offers a trusted, collaborative platform to accelerate digital health transformation and cross-border data exchange. "Our task is to build a global community that accelerates interoperability along the entire chain from research to care through the use of HL7 FHIR."

Jesper Kjærs from the Danish pharmaceutical company Novo Nordisk called for more speed and efficiency. Overall, however, the participants agreed that the success of the EHDS depends crucially on transparency and active public participation in the ongoing consultation. "You can't talk about digital health systems without talking about cybersecurity or data protection. Together with the Member States, we have created a framework that promotes innovation while ensuring transparency, data protection and the dignity of the people behind the data," said Marcella. The national particularities in the implementation of the EHDS are still likely to pose a challenge.

(mack)