Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough

IF 15.7 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2026-08-01 Epub Date: 2026-07-27 DOI:10.1016/j.lanepe.2026.101784

Hannah van Kolfschooten, Georges Hattab, Franziska Bächler, Giulio Stefanini

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引用次数: 0

Abstract

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.

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欧盟安全心脏计划中的人工智能：仅靠预测是不够的

欧盟委员会的“安全心脏计划”将人工智能定位为加强心血管疾病预防、诊断和护理的关键工具。尽管人工智能带来了重大机遇，但“安全之心”计划可能夸大了其影响，因为它将技术能力置于实施准备之上。本观点借鉴欧盟政策文件、世卫组织/欧洲报告以及有关人工智能治理和心血管护理的文献，通过政策和法律分析，审查了在《安全心脏计划》中赋予人工智能的作用。报告认为，人工智能的技术表现与其现实世界的临床影响之间存在着持续的“利益差距”，这反映了实施人工智能的体制、运营和法律障碍。该观点进一步分析了围绕监管、责任和患者权利的法律不确定性如何阻碍人工智能与心血管护理的负责任整合。它的结论是，人工智能应该嵌入健全的法律、制度和操作框架中，以改善心血管疾病的预后，而不仅仅是产生更准确的预测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.