The proposal for the European Health Data Space (EHDS) was unveiled yesterday (3 May) by Commissioner for Health and Food Safety, Stella Kyriakides and Commission Vice President Margaritis Schina.
Kyriakides said the EHDS will give patients safe access to their data and enable data-sharing for research and innovation. “It’s going to be a fundamental game changer,” she said.
BUILDING A RESILIENT SYSTEM
Europe’s aging population, a shrinking workforce and the rise in telehealth, make the EHDS a vital tool in shaping a sustainable and resilient healthcare system across the continent, according to Petra Wilson, managing director of Health Connect Partners and EU policy advisor to HIMSS. “It allows for the know-how of healthcare professionals to travel, to support the treatment of patients without patients necessarily having to travel on their own. That’s because it foresees its far higher integration of telemedicine than we had before.”
The proposal also addresses the secondary use of data—the deployment of patient data in research and innovation. This will facilitate the study of all kinds of research questions, said Markus Kalliola, the coordinator of Towards a European Health Data Space (TEHDAS), a project supporting the development of the EHDS involving 25 countries. The EHDS will create a clearer and more coherent system, which will make it easier for researchers who want to access data from multiple countries to do so, he said. “For the first time it will give us a harmonized framework for the legal groundwork for the secondary use of health data in the EU.”
In addition, the data space will yield information that can be used in public health policy. “We have seen a lot of decision-making using health data to for example fight the epidemic,” Kalliola said. “The EHDS will enable the secondary use of health data both for research and decision-making and also for innovation purposes.”
The proposed regulation increases the legal certainty in Europe’s health data environment by defining the roles of different stakeholders and strengthening patients’ rights, said Anastasiya Kiseleva, a doctoral researcher at VUB and CY Cergy Paris University who published an articles last year on the legal obstacles facing the EHDS.
But as discussions continue, law-makers will need to ensure that the language in the regulation agrees with that of instruments like the AI Act, the Medical Devices regulation and other upcoming pieces of legislation, Wilson said. “The proposed legislation has a heavy emphasis on the interoperability of electronic health records across the EU but we also need to make sure that European legislation in itself is properly interoperable.”
It also poses a challenge to member states, which will need to invest in their capacity. The EHDS is designed to connect data hubs across member states, but currently just a few countries—like France, Germany, Finland and the Netherlands—have such hubs in place.
Industry leaders welcomed the new system, with Johannes Schildt, the CEO of Kry, a digital health company, stating, “If we’re serious about overcoming the long-term pressures on our health systems and if we really want patients to benefit from new technologies, we need to act now at a European level to tackle a fragmented digital health market and the lack of interoperability of health data.”
And policy-makers are optimistic. “Ultimately the only way forward for us to improve our health systems and improve the services to citizens is through digitalization and using all the data out there,” Kyriakides said.