aceBeyond 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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A systematic review published June 30, 2026 searched PubMed, Scopus and ScienceDirect for 2020-2025 literature on AI in cardiology and HTA. After screening 223 records, six studies were included, covering stroke outcome prediction, atrial fibrillation screening and wearable-based monitoring, supported by 17 documents, and compared against three HTA frameworks for EU HTAR alignment.
The synthesis matters because it documents a mismatch between increasing clinical use of cardiovascular AI and the capacity of existing HTA processes to evaluate dynamic, adaptive tools under new EU regulation. It remains uncertain how to operationalize lifecycle adaptability, post-deployment evaluation and consistent cardiologist engagement within HTA for these technologies.
- Search covered PubMed, Scopus, and ScienceDirect for January 2020 to December 2025 and screened 223 records to include six studies.
- Included studies covered stroke outcome prediction, atrial fibrillation screening and wearable-based monitoring and were supported by 17 documents.
- Four studies incorporated real-world data, but most focused on clinical or economic performance without referencing formal HTA frameworks.
- Comparative analysis examined three HTA frameworks for alignment with EU HTAR evidentiary requirements.
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.
The rundown
The review synthesized six studies identified from 223 records, covering applications such as stroke outcome prediction, atrial fibrillation screening and wearable-based monitoring, with four studies incorporating real-world data.
Authors performed narrative synthesis and comparative analysis of three HTA frameworks against EU HTAR requirements, finding most studies focused on clinical or economic performance without referencing formal HTA frameworks and noting stakeholder engagement was inconsistently reported.
Sources
- Peer-reviewedAnnals of Translational Medicine2026-06-30
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