EHDS: “Regulation Must Stay Agile”

Health data is no longer a byproduct of care – it’s becoming one of the EU’s most strategic resources. In a conversation with the Data2Value Initiative, Eva Hrnčířová, Commission Spokesperson for Health and Food Safety tells Artur Olesch how the European Health Data Space (EHDS) aims to turn health data into real-world value.

A Competitive Edge for European Healthcare
The EHDS is built to do more than digitize health records. It sets out to unlock secondary uses of health data – for research, innovation, and smarter policymaking – while giving people real access and control over their data.

“The EHDS will create an unprecedented boost for research, innovation, and public health policy,” says Hrnčířová. “It enables secure, trustworthy data use to unlock new treatments, better prevention, and faster crisis response.”

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Beyond individual impact, it aims to build the foundation for a resilient, competitive European healthcare ecosystem. How? Through legal clarity, shared standards, and strong governance that reduce friction across borders.

Regulation That Enables, Not Blocks
For health data to drive innovation, it must be trusted, accessible, and interoperable. That’s why EHDS is part of a broader legislative push – aligned with the AI Act and upcoming Biotech Act – to streamline innovation across Europe.

“The EHDS will make available the data needed for AI development in healthcare,” Hrnčířová explains. “Meanwhile, the AI Act ensures these tools are safe, transparent, and privacy-respecting.”

Add to that regulatory sandboxes – safe zones for startups to trial AI tools in real conditions. The result? Faster innovation, fewer bureaucratic roadblocks.But the Commission knows that red tape is still a challenge. Particularly for SMEs. That’s why it’s already reviewing medical device and clinical trial rules to simplify them.

We will streamline the regulatory environment while keeping health protection high.

From Regulation to Real-World Impact
With the EHDS Regulation now in force, the real work begins: implementation.

“The EHDS is a milestone. But the coming years will be critical to ensure it’s fully and adequately implemented,” Hrnčířová stresses.

That means deep collaboration – from national authorities and hospitals to startups and research hubs. Only together can Europe build a truly data-driven health system.

What’s at stake?

For clinicians: faster, fuller access to patient data.
For citizens: cross-border care and ownership of their data.
For innovators: lower barriers to build new solutions.

“This isn’t just a tech project. It’s a cultural one,” Hrnčířová concludes. “It’s about building a healthcare system that’s connected, personalized, and equitable.”

Bottom line
As the Data2Value Initiative emphasizes, building infrastructure is only part of the puzzle. The bigger goal? Empowering every layer of the health system to turn data into action. The EU’s bold vision shows that with the right rules, data can become one of the most powerful forces in healthcare today.

Eva Hrnčířová is European Commission’s spokesperson with responsibilities for Social rights & Skills, Preparedness, Equality, Culture & Health.