NEW YORK – A regulation establishing the European Health Data Space (EHDS) will officially come into effect later this month, creating a framework for collecting and sharing electronic health data, including genomics data, across the EU.
The introduction of the EHDS overlaps with ongoing efforts in Europe to make genomics data more accessible to researchers, such as the 1+ Million Genomes (1+MG) initiative. Makers of in vitro diagnostics also view the EHDS favorably, as more standardized data will enable them to create better tests and collect data on them. But the genomics and diagnostics communities are keen to see clear implementation objectives set as the EHDS is rolled out over the next decade.
The European Commission published a proposal for the EHDS in May 2022. The regulation aims to standardize the collection and provision of electronic health data across the EU, both to make this data more accessible to individuals as well as to support its reuse in research, for example. This January, the Council of the EU formally adopted the regulation, which will enter into force on March 26.
One catalyst for the EHDS was the COVID-19 pandemic, which is referred to throughout the regulation, but also discrepancies in the way data is collected and stored across the EU.
Most familiar with the regulation stress that it will be implemented in stages and that it could take a decade for it to be realized. By March 2029, data exchanges for the first group of priority categories, such as patient summaries under primary use, are expected to go live. The rules on secondary use data, which include genomics data, will begin to apply after 2029.
Expectations on implementation
"There is a need to avoid fragmented national approaches and for further clarification on key aspects, such as the scope and definitions within the regulation," said Miriam D'Ambrosio, a spokesperson for MedTech Europe, a trade association that represents in vitro diagnostics manufacturers.
D'Ambrosio underscored that the data generated by medical devices and IVDs forms an "integral part" of the health data ecosystem and that digitalization of that system through the EHDS can only lead to "better, faster, and more efficient healthcare." Through making data more accessible, interoperable, and better administered, IVD companies only stand to win.
"The EHDS has the potential to unlock new opportunities," said D'Ambrosio. "It can help to further develop AI in diagnostics, predictive analytics, and treatment optimization."
But there are concerns about regulatory complexities, such as the broad definition of EHR systems in the regulation, as well as associated technical requirements for them. She also said that achieving harmonized implementation, particularly in defining the scope of health data and the governance mechanisms for the secondary use of electronic health data, will be "essential" for the EHDS to fulfill its potential.
"In coming years, secondary legislation will further define many details, making it crucial to involve stakeholders early in the process to ensure alignment with best practices for the practical implementation," said D'Ambrosio.
The genomics community also believes it will benefit from the implementation of the EHDS, and may play an advisory role, given the expertise it has developed through its data sharing efforts.
"The conversation between EHDS and 1+MG is ongoing," said Ivo Gut, director of the Centro Nacional de Análisis Genómico (CNAG) in Barcelona. "My impression is that EHDS is looking to us for guidance on how to bring the genomic information into the fold somewhere in the future."
CNAG has been involved in several projects to realize the goals of 1+MG, which aims to make more than a million genomes accessible to European researchers, such as the €4 million ($4.3 million) Beyond 1 Million Genomes and the €40 million Genome Data Infrastructure project.
In some countries — such as Finland, Denmark, and Estonia — healthcare data, including genomics data, already aligns to the EHDS. "Northern European countries are well placed for EHDS because of the way their healthcare systems are run," said Ewan Birney, deputy director general of the European Molecular Biology Laboratory and director of the European Bioinformatics Institute. Other countries will have to upgrade their internal EHR systems while also making them accessible for secondary use within the EU.
The broad responsible access to research data enabled by the EHDS is "something the genomics community has always wanted," he said, cautioning that the "devil is in the details" as countries begin to implement the regulation.
He cited the Federated European Genome-Phenome Archive (FEGA) as a good example of a federated platform that could inform the EHDS. Within FEGA, data is stored in national nodes but is accessible to all researchers who are granted access. FEGA is co-led by EMBL-EBI and the Center for Genomic Regulation in Barcelona.
Juan Arenas, head of the project management offices for ELIXIR, an organization that coordinates European life sciences infrastructure, as well as deployment lead on the GDI project, which creates the infrastructure for the 1+MG project, said that the EHDS "will unlock access to healthcare data for secondary use at the EU level, as the legislation forces all healthcare data holders to make their data discoverable and share it once a valid request has been approved."
Strengths of the regulation include the support of single data access requests, he said, as well as the planned creation of an EU datasets discovery portal that will be an aggregation of national portals. The data will also be made accessible via a secure processing environment, he said.
There are some potential kinks, though. The data might still be heterogeneous, at least during the initial years, meaning that it will require additional standardization and quality control. Also, data will only be available for processing for the time of the study, he said, meaning any future requests will initiate a new data access process.
According to Arenas, different European digital infrastructure consortia (EDICs) will likely be able to complement the EHDS, including the GDI and the European Federation for Cancer Images project, both of which could be considered "authorized participants" in the EHDS — contacts that will supply the cross-border infrastructure for secondary use of electronic health data.
'A vital development'
According to Torsten Kiesner, spokesperson for the German Diagnostics Industry Association (VDGH), two projects are already underway to support the harmonized implementation of the EHDS. One is a joint action called Xt-EHR, which commenced in November 2023 and aims to develop a design for the primary use of data, as well as documentation and common specifications for EHR systems. There is also the Second Joint Action Towards the European Health Data Space (TEHDAS2), started in 2024, that focuses on addressing the secondary use of health data and aims to develop guidelines and technical specifications to enable data access and improve European collaboration for research.
According to Kiesner, VDGH has been providing feedback on the technical aspects of the EHDS, which will be used to outline EU-wide guidelines. Specifically, Germany's National Digital Health Agency, which is responsible for the Xt-EHR project in Germany, has asked VDGH to comment on technical specification categories in coming months. One category is medical test results, including laboratory and other diagnostic results and related reports, and covers implementation guides and technical requirements for EHR systems.
Kiesner said the EHDS is a "vital development" for the IVD industry that will stimulate research and development, support cross-border collaboration, and reduce complexity in bringing new products to market. He noted that Germany will implement the Logical Observation Identifiers Names and Codes (LOINC) standard in 2026 to secure laboratory data in German EHRs.
"For the industry, it would be a major win if the same standard were used in France, Italy, or Poland," Kiesner said. "Otherwise, manufacturers will have to implement different standards for their products depending on the country in which the product will be deployed."
He also noted that the EHDS will support "broader, more comprehensive research and development" across the EU. "In the future, a research company will be able to go to any member state and access this data to develop new diagnostic methods," said Kiesner. "This, in turn, can help to improve diagnostic accuracy and healthcare outcomes."