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The European Union's Artificial Intelligence Act (AI Act), published in July 2024, is a pioneering horizontal regulatory framework aimed at ensuring the ethical and safe integration of AI technologies across sectors, including healthcare. While it offers the potential to improve patient care and drive innovation, it also presents challenges for healthcare providers, such as identifying high-risk applications, ensuring transparency in algorithms, and mitigating data bias. However, there are several challenges in its implementation. These include unclear guidance for certain technologies, the need to ensure fairness for diverse patient populations, effective monitoring of AI performance after deployment, and clarifying responsibility in cases of errors. Additionally, varying levels of resources among EU countries may lead to inconsistent implementation of the regulations. This article explores the core elements of the AI Act and its relevance to cardiology and identifies key gaps and unanswered questions that need to be addressed to effectively advance AI-driven medical practices.
Vardas et al. (2025) studied this question.