Beyond the algorithm: health technology assessment frameworks for AI in cardiology under the European Union Health Technology Assessment Regulation: a systematic review
Background: Artificial intelligence (AI) is increasingly used in cardiovascular care to support diagnosis, monitoring and clinical decision-making. However, its dynamic and adaptive nature challenges conventional health technology assessment (HTA) frameworks, which are typically designed for static interventions. This review aims to assess how existing literature supports HTA-relevant evaluation of AI-based cardiovascular technologies and examine their alignment with the evidentiary requirements outlined in the…

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