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Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough
Hannah van Kolfschooten1, Georges Hattab2,3, Franziska Bächler1
1Centre for Life Sciences Law, University of Basel, Peter Merian-Weg 8, 4052, Basel, Switzerland.
The Lancet Regional Health. Europe
|August 7, 2026
Summary
The European Commission's Safe Hearts Plan highlights artificial intelligence (AI) for cardiovascular disease care. However, AI's real-world impact is limited by implementation barriers, not just technical potential.
Area of Science:
- Cardiovascular Medicine
- Health Policy
- Artificial Intelligence Governance
Background:
- The European Commission's Safe Hearts Plan identifies artificial intelligence (AI) as crucial for cardiovascular disease (CVD) prevention, diagnosis, and care.
- The plan emphasizes technological advancement but may overlook practical implementation challenges.
Purpose of the Study:
- To critically examine the role and impact of AI in cardiovascular care as outlined in the Safe Hearts Plan.
- To analyze the gap between AI's technical capabilities and its actual clinical benefits.
Main Methods:
- Policy and legal analysis of EU policy documents and WHO/Europe reports.
- Review of literature on AI governance and cardiovascular care.
Main Results:
- A "benefits gap" exists between AI's technical performance and its clinical impact due to implementation barriers.
- Institutional, operational, and legal hurdles impede the effective integration of AI in cardiovascular settings.
- Legal uncertainties regarding regulation, liability, and patient rights pose risks to responsible AI adoption.
Conclusions:
- AI's potential in cardiovascular care is constrained by factors beyond technological capacity.
- Robust legal, institutional, and operational frameworks are essential for realizing AI's benefits in improving cardiovascular outcomes.
- Focus should shift from AI prediction accuracy to its responsible integration for tangible patient benefit.