What is the European Health Data Space?

The European Health Data Space (EHDS) is a regulation that aims to establish a common framework for the use and exchange of digital health data across the European Union. It was adopted by EU Council and Parliament in March 2025, and is the first ‘data space’ to take shape as part of the broader European strategy for data. It is expected that there will eventually be other data spaces, such as finance, agriculture, or energy data spaces.

What Does it Do?

There are two main components to the EHDS: 

Primary Use (Clinical Care): This is being realized through interoperability requirements for electronic medical records (broadly defined to include many kinds of systems) as set out in the MyHealth@EU framework. This is required to be fully implemented in all MS by March 2029. It offers individuals the right to access their electronic health records immediately and free of charge in any EU member state (MS). It also allows for cross-border EMR access for medical care, and for cross-border prescriptions.

Secondary Use (Research, Innovation, Policymaking): This component establishes a new regulatory regime intended to promote the use of health data (broadly defined, and includes 15 categories) for research, innovation, and policymaking. Up to now, the sharing of digital health data in Europe has been characterized by heterogeneous national regulations, and a patchwork of digital and paper-based processes, consent requirements, and institution-specific data access and use agreements. The EHDS will attempt to streamline data access for data users.

How Will it Work?

Under the EHDS, ALL data holders (Big Tech, hospitals, clinics, pharma, etc.) as defined in the regulation would be required to disclose their data holdings to “health data access bodies” (HDABs) in each MS. In some cases, national institutes already exist and will assume the role of HDAB (e.g., Findata). In other cases they will be created from scratch. 

HDABs will assess requests for data from 'data users’ (for purposes outlined in the regulation), send the requests to the 'data holders', and is also responsible for setting and collecting fees for data preparation. It is also responsible for publishing a national data catalogue. The data are then made available in a secure processing environment (details of which are to be determined in future implementing acts). If a data user wants to access data from multiple organizations, they can submit a single application to one HDAB of their choice, and that HDAB will coordinate and forward the request to the other HDABs.

When Will it be Implemented?

The EHDS has an unusually long implementation timeline. While the Regulation entered into force in March 2025, the Commission will continue to develop 20+ delegated and implementing acts into 2027, with secondary use provisions applying four years from entry into force in March 2029. These delegating and implementing acts are intended to supplement or amend certain non-essential elements of the law, and to ensure uniform implementation of EU law across all Member States, respectively. In contrast, for example, the timeline from Council adoption to full applicability in all MS for the GDPR was only two years.

There are a number of active pilots for primary and secondary use which you can find here.

Of note is that non-EU 'third countries' such as the UK and Canada could eventually join the EHDS starting March 2034, provided they meet the criteria laid out in the regulation (including reciprocity of data flows).

Main Takeaways

In summary, the EHDS is an ambitious regulatory regime that sets out the conditions for health data sharing, access, and use within the EU. Because of the scale and scope of the initiative, variations in degrees of digital maturity among MS, and the sensitivity of health as a domain, the EHDS warrants close attention as it continues to unfold.