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…
Adaptive AI tools for cardiovascular care challenge conventional HTA frameworks designed for static interventions, resulting in indirect alignment with EU HTAR requirements and inconsistent engagement of cardiologists in evaluation.
Evidence base is limited to six studies meeting inclusion criteria after screening 223 records, and lifecycle considerations were underreported, limiting generalizability to broader cardiology AI deployment.
Evidence
- Peer-reviewedAnnals of Translational Medicine2026-06-30
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Truvace Impact Record TRV-2026-0316, v1: “Beyond the algorithm: health technology assessment frameworks for AI in cardiology under the European Union Health Technology Assessment Regulation: a systematic review.” Truvace, 2026-07-20. /record/TRV-2026-0316 (accessed at citation time). sha256 d1cf5142445d980a…
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