The European Health Data Space: an ambitious framework for health data, but more clarity is needed on how it will work

Today, the European Commission published its long-awaited proposal for the European Health Data Space (EHDS). We support this decisive step towards a harmonised internal market for health, although aspects of budget, governance, and interplay with other legislation will need to be clarified.

Director-General of DIGITALEUROPE Cecilia Bonefeld-Dahl said:

“The Commission’s proposal, after some delays, seems to have struck the right balance between boosting data access for primary and secondary uses, and ensuring data protection and security. But we need to act much faster if we want the infrastructure to be up and running in all Member States by 2030.

Moreover, it is good to see progress in allocating funding for this ambitious undertaking, but more clarity is needed on how this will be secured and coordinated. It’s vital that the EU and the Member States invest effectively in infrastructure, as well as strengthening digital health skills.

Overall, the EHDS proposal is an ambitious step forward, but many of its concrete aspects will need to be implemented further down the line, which could result in another fragmented, GDPR-style approach, and deviation from the needs of patients and innovators. When shaping the EHDS, all those who have a stake – patient associations, but also health bodies and industry – should be involved.”

Key aspects that can make or break the EHDS’s success

• The EU should play a bigger role in harmonising the Single Market for digital health and data, while Member States and regions should retain control over how health is delivered. The current proposal leaves room for many of its concrete aspects to be realised through later Implementing Acts, risking increasing fragmentation and delays further down the line.

• Interplay with other data legislation, such as the GDPR, Data Act, Medical Device Regulation and AI Act. Parts of the proposal fail to be crystal-clear on the scope and interactions with these.

• Enough budget from both the EU and Member States. It is good to see that the Commission has made efforts to increase the resourcing. However, we hope to see coordination among EU and national governments geared towards effective spending.

• Ensuring that investments in the EHDS’s data re-use infrastructure will deliver real benefits. It is great that the proposal lists R&I and artificial intelligence development and testing as data re-use purposes. It is key that they remain in the final legislation. They are vital areas for European health innovation and will ensure that the significant investments needed will have a tangible human and economic benefit.