Stakeholders doubtful EU health data space will launch on schedule – EURACTIV

By Barbora Pištorová and Ondřej Plevák |
The Commission hopes that by the end of its current mandate on 31 October 2024, the legislative process will be completed, with the EHDS operational in 2025. [SHUTTERSTOCK/Tero Vesalainen]

Stakeholders expressed concern that the European Health Data Space (EDHS), aimed at reforming the sharing of health data across hospitals around the EU, will launch as planned in 2025 due to a large number of issues still to be addressed.
Read the original Czech article here.
The EHDS seeks to bring order to the currently fragmented European healthcare system through the creation of a ‘digital data ecosystem’ that will streamline access to medical records for patients and regulate access for researchers.
The proposal is a leading element of the European Data Strategy, aimed at making the EU a “world leader” on the data stage. The healthcare sector is a pioneer, to be followed by other data ‘spaces’ in the future, such as in tourism or agriculture.
The Commission hopes that by the end of its current mandate on 31 October 2024, the legislative process will be completed, with the EHDS operational in 2025.
However, at a conference on the status of legislative proceedings in Prague, which is currently at the helm of the rotating presidency of the EU Council, a number of stakeholders warned that it may take much longer, citing care needed in the setting of rules and sufficient preparation of member states for implementation.
As the EU executive’s proposal for an EU health data space moves forward, experts and Commissioners emphasised that it will not be workable without a significant degree of trust from citizens.
One roadblock in the process is the harmonisation of patient information systems. Such systems can vary significantly at both the state and regional levels, complicating agreements on common standards.
For the Commission, an immediate priority is to address the inconsistent level of digitalisation across member states. According to a recent Surfshark survey, within Europe, the Nordic countries lead while Eastern Europe lags behind.
“We have to realise that some countries will simply not be able to keep up with the emerging legislation,” Robert Hejzák, head of the Czech National Association of Patient Organisations, said.  
The digitalisation of healthcare is a costly project and is currently supported by various tools, including the EU’s Recovery and Resilience Facility, EU4Health Programme or Horizon Europe. However, experts have argued that an efficient data ecosystem could save money in the future. 
Besides funding, the interconnection of health databases will require the transfer of some competencies from the national to the European level. Such a move is sensitive, especially since health governance has always remained a national competence. 
Still, the EU can build upon existing systems. As Fulvia Raffaelli from the European Commission’s health service, DG SANTE, highlighted, health data sharing is “an evolution rather than a revolution”.
For example, she described, the MyHealth@EU infrastructure for electronic cross-border health services is now operating on a voluntary basis.
This makes it easier for patients to access healthcare abroad thanks to digital profiles that include, for example, e-prescriptions. Eleven countries already participate in this project and many more are expected to join by 2025.
European doctors have raised concerns about medical ethics, the burden on doctors, and the national competence of member states in the European Commission’s proposal for the European Health Data Space (EHDS), currently being discussed in the European Council and Parliament. 
Another key objective of the EHDS is the so-called ‘secondary’ use of health data for research, innovation, policy-making and regulation.
Thirteen EU countries already have a centralised system in place that can generate such data, but nothing yet links them into a single EU-wide network.
Such a network would be welcomed by the pharma industry which faces administrative barriers while accessing various sources of data.
“Sometimes it can take up to two years. This is unsustainable,” said Thomas Brookland from the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Pharma industry representatives also point out that better data access could boost European research, development and innovation, thus becoming more attractive to investors. 
The ambitious goals of Europe’s Beating Cancer will be out of reach without prioritising the gathering of necessary data to gain a more accurate picture of inequalities in cancer care, according to a health economist.
With Europe positioning itself as a world leader in personal data protection, health data security is at the heart of discussions on the development of the EHDS. 
While the US and China are considered by some to be more advanced in health data sharing, the EU is seeking to match them – while ensuring the exchange, use and reuse of health data are in accordance with General Data Protection Regulation (GDPR) standards.
As such, EU officials have emphasised that although the data would be available in a single pan-European database, it would always remain physically at the national level.
Despite the initial decision to assign the European Health Data Space exclusively to the European Parliament’s civil liberties committee (LIBE), it has now been agreed that the committee for health (ENVI) will co-lead the file, which expands the EU data regulation.
[Edited by Giedrė Peseckytė/Nathalie Weatherald]


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