The European Union may have built the world’s most ambitious health data framework with the European Health Data Space, but it has overlooked one crucial element: citizens. While Brussels focuses on rules and infrastructure, Europeans are already seeking health advice from American AI platforms, filling a gap the EU has yet to address.
That tension surfaced during a structured dialogue between the European Parliament’s health committee (SANT) and Health Commissioner Olivér Várhelyi, where Romanian MEP Vlad Vasile-Voiculescu (Renew/RO) warned that the EHDS risks becoming infrastructure without a public interface.
“The EHDS gives us the plumbing,” MEP Voiculescu said. “When will we build something that citizens can actually use?”
Health data flowing to the US
MEP Voiculescu argued that while the European Health Data Space (EHDS) was designed primarily for healthcare systems and professionals, millions of Europeans are already using generative AI tools such as ChatGPT to ask questions about symptoms, interpret laboratory results and seek preventive health advice.
“Every one of those conversations transfers sensitive personal health data to servers governed by U.S. law,” he warned. “We are living in a paradox”.
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The result, he argued, is a growing contradiction at the heart of Europe’s digital health strategy.
“The EU regulates health data more strictly than any other jurisdiction in the world,” Voiculescu pointed out. Yet the block does not present citizens with European health tools. “The result is that European health data flows to the United States by default, not by choice,” he added.
When will we build something that citizens can actually use?
— MEP Vlad Vasile-Voiculescu (Renew/RO)
The intervention highlighted how quickly the policy debate around the EHDS is evolving. Until now, discussions around the framework have largely focused on hospitals, researchers, interoperability and cross-border exchange of medical data. But the rapid adoption of consumer-facing AI tools is shifting attention toward a different question: whether Europe risks losing control over how citizens interact with health information in everyday life.
From infrastructure to citizen tools
The exchange also exposed a broader gap between Europe’s regulatory ambitions and its ability to develop digital products citizens actually use. The EU has become a global rule-maker in areas ranging from privacy to artificial intelligence governance, yet American technology companies increasingly dominate the interfaces through which Europeans access digital services, including health-related information.
The Safe Hearts Plan will create a whole new generation of healthcare data, and we want this to stay for the benefit of our patients.
— Health Commissioner Olivér Várhelyi
For some policymakers, this is no longer simply a technology issue but a question of sovereignty. If Europeans increasingly rely on non-European AI systems for health guidance, prevention and interpretation of medical information, questions around legal jurisdiction, trust, data localisation and strategic autonomy become harder to ignore.
MEP Voiculescu argued that Europe now needs to move beyond infrastructure and begin developing citizen-facing tools built on European systems and values. He called for “a European health prevention application built on EU infrastructure, compliant with EU values, and designed to keep European citizens’ health data on European soil.”
Commission signals openness
Health Commissioner Várhelyi did not dismiss the concerns. Instead, he acknowledged the trend directly and shared the Commission is already exploring such applications through its broader prevention agenda and the Safe Hearts Plan.
“Yes, I see the same trend,” Commissioner Várhelyi said.
“We already, in the Safe Hearts Plan, try to work out such an application,” he pointed out, adding that the Commission intends to allocate €20 million this year as part of the initiative.
“Of course, the Safe Hearts Plan will create a whole new generation of healthcare data, and we want this to stay for the benefit of our patients.”
The comments suggest the Commission increasingly sees digital prevention and citizen-facing health tools as part of Europe’s wider health sovereignty and prevention agenda. That would represent a significant evolution in EU digital health policy, which until now has focused primarily on regulation and governance rather than public-facing platforms.
Europe’s next digital health challenge
The debate unfolding around the EHDS increasingly mirrors a broader challenge facing Europe across multiple technology sectors. Regulation alone may shape the rules of the digital economy, but it does not automatically create competitive ecosystems or trusted consumer products.
The EHDS may become one of the world’s most advanced frameworks for health data exchange. But as generative AI becomes embedded in daily health decisions, Brussels is beginning to confront a more uncomfortable question: whether Europe is building the infrastructure of digital health while American companies are building the actual relationship with citizens.
