The European Commission’s Safe Hearts Plan positions AI as a key tool for enhancing the prevention, diagnosis, and care of cardiovascular disease. Although AI presents significant opportunities, the Safe Hearts Plan may be overstating its impact by prioritising technological capacity over implementation readiness. This Viewpoint examines the role assigned to AI within the Safe Hearts Plan through a policy and legal analysis, drawing on EU policy documents, WHO/Europe reports, and literature on AI governance and cardiovascular care. It argues that a persistent “benefits gap” exists between AI’s technical performance and its real-world clinical impact, reflecting institutional, operational, and legal barriers to implementation. The Viewpoint further analyses how legal uncertainty surrounding regulation, liability, and patients’ rights may hinder the responsible integration of AI into cardiovascular care. It concludes that AI should be embedded within robust legal, institutional, and operational frameworks to improve cardiovascular outcomes rather than simply generate more accurate predictions.
Please cite as: Hannah van Kolfschooten, Georges Hattab, Franziska Bächler & Giulio Stefanini, ‘Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough’ (2026) The Lancet Regional Health – Europe, 67:101784, https://doi.org/10.1016/j.lanepe.2026.101784
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