How will the European Health Data Space benefit EU citizens?
The EHDS will give citizens more control over their health data. They will have immediate and free access to their health data in an electronic form and will be able to share their data with health professionals. This is called the primary use of the data.
The data will be presented in a common European format, meaning that it can be used and accepted everywhere in the EU: if you have an accident or become ill when working or travelling in a different Member State, the doctor or hospital there will be able to get your health records from your general practitioner, and your GP will be able to receive the discharge report back from the hospital. People will also be able to fill their prescriptions anywhere in the EU.
This is obviously a great boon to cross-border healthcare, but even at home, people might change doctors or be seeing several specialists or being treated in different hospitals at the same time. It’s important that everyone is on the same page and aware of the patient’s medical history and of any medications or treatments currently prescribed.
Patients will also be able to add information, restrict access, know who accessed their data and request corrections if any of the data is incorrect.
How will the EHDS benefit industry and researchers?
There’s a saying that necessity is the mother of invention. When industry and researchers know more exactly what the existing health problems are, it will be easier for them to find solutions. Stimulating innovation in medical products and devices will help provide better, more personalised care that will treat and save lives.
It’s about what we call “secondary use of data” – that is, the re-use of health data for a different purpose that the one it has been collected for, by industry, regulators, innovators or researchers. Such use could also lead to the development of new medicinal products or new medical devices, including using Artificial Intelligence. Thanks to the EHDS, health data users will be able to see what data is available, where, and of what quality. They will also be able to access the data in a more effective and less expensive way, through a health data access body that maintains state of the art privacy and security.
There will also be innovation around the electronic health records (EHR) systems themselves. Having an EU-wide market for these systems, with same standards and specifications, will create a level playing field for service providers. This could stimulate competition, with various companies offering competing products catering for different needs and price ranges.
Is the EHDS one big common databank?
No, the EHDS is not a single health database where every EU citizen’s health data is centralised.
It’s a framework that provides governance and infrastructures for using health data.
We are not touching how Member States organise the storage of health records. Member States are responsible for their own internal organisation of their health systems. Some Member States have centralised systems, others decentralised ones.
What we’re doing is ensuring that health data repositories across the EU are interconnected through trusted bodies, making it easier for individuals, healthcare providers, researchers, policy makers and others to access and use the data, while maintaining strict privacy and security safeguards.
How does the EDHS go from being a proposal to being an implemented legal framework?
As is the normal process in the EU, the Commission first submits a legislative proposal to the Parliament and Council of the EU, who must agree on the text for it to become Union law.
The Parliament and the Council have agreed on the proposal, with some modifications but retaining the essential elements concerning both the primary and secondary use of health data. Among the modifications are more opt-out options: Member States will have the option to let patients completely opt-out from the infrastructures set up for primary use.
For secondary use, patients can opt-out from having data be made available for research and certain other purposes. However, in some specific situations of public interest and on a case-by-case basis, MS will have also the possibility to grant access to this data, in order to gather more complete and accurate data for research and policy making.
The co-legislators added a requirement that manufacturers will have to run their Electronic Health Records systems through automated testing environments and provide the test reports as part of the technical documentation of their products when placing them on the market.
Finally, they extended the transition periods, giving stakeholders more time to prepare.
Next up is the final vote later this month in the Plenary session, and if all goes to plan, the EHDS will be published in the Official Journal this autumn.
With the longer transition periods, we expect the EHDS to be up and running in 2028.
How will Member States transition to using the EHDS?
We aren’t starting from scratch. The EHDS will build on the existing voluntary cross-border infrastructure, MyHealth@EU, that allows for the exchange of health data across borders. The EU will continue to provide funding for the Member States to get ready and overall, the Commission will provide over 810 million to support the European Health Data Space.
But it’s very much a team effort that will require digitalisation at local, national and regional level. The EU and the Member States are taking this ambitious step together, and it’s a substantial investment of money, time and effort. But it’s a sound and necessary investment that will ultimately save billions of euros, enormous time and effort, and most importantly – lives.
