AI to shape EU health policymaking without new rules

Artificial intelligence (AI) is poised to revolutionise healthcare, from machine learning easing diagnoses to the discovery of innovative drugs—but no dedicated AI for healthcare legislation is in the Commission’s pipeline.

“This is the way the whole technology is evolving. It is impossible nowadays not to use artificial intelligence in the healthcare sector,” said EU Health Commissioner Olivér Várhelyi speaking at the unveiling of a new communication on hospital cybersecurity.

While the EU has started to look into the use of such cutting-edge solutions in the health sector, Várhelyi ruled out a dedicated legislative initiative for now.

Still, it is “very clear” to the Commissioner that the healthcare sector will go down this road in the next five years.

“This is why, when we are going to design basic proposals, we will focus very largely also on the possible use of artificial intelligence,” he said.

He acknowledged that AI will shape the Commission’s agenda, with specific focus areas woven into broader legislative efforts.

Among these is the Biotechnology Act, slated for 2025, which aims to streamline regulations for life sciences seeking to “bring biotech from the laboratory to the factory and then onto the market,” as highlighted in Commission President Ursula von der Leyen’s political guidelines.

But AI won’t just guide the policymakers’ work on product development but could also come in handy for treatments and diagnostics, he said.

Várhelyi highlighted the forthcoming EU’s cardiovascular health plan as an example of that, as it will seek to harness AI for personalised medicine, predictive health analytics, and tailored patient care pathways.

“Artificial intelligence can be the tool helping patients to see the risks posed by cardiovascular diseases,” he said.

The Commissioner also highlighted the role of the recent EU Health Data Space framework, which facilitates secure collection and analysis of vast health datasets. This foundation, he argued, is essential for advancing AI-driven healthcare innovations.

“We have not only a potential but a duty to use [this health data] and let it grow in this legislative mandate into a completely new era of healthcare,” he said.