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This paper presents the AQuAS AI Assessment Guide, a methodological framework developed to support the evaluation of digital health technologies (DHTs) that incorporate artificial intelligence (AI). Designed collaboratively by the Agency for Health Quality and Assessment of Catalonia (AQuAS) and the TIC Salut Social Foundation, the guide defines 13 assessment domains encompassing clinical relevance, technical performance, ethical considerations, regulatory compliance, and broader system and societal impact. The guide aims to foster a robust, evidence-based and context-sensitive evaluation of AI solutions across different stages of development and diverse use cases. This article outlines the background, development methodology, and structural composition of the guide, and discusses its potential uses and contributions to responsible innovation in health systems.

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The Assessment of AI-Based Digital Health Technologies from the Perspective of HTA Bodies. The Case of AQuAS’ AI Assessment Guide

  • 会议论文

  • 发表日期：

    2026年

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  • Carolina Moltó-Puigmartí,
  • Susanna Aussó Trias,
  • Maria Bretones Vallejo,
  • Didier Domínguez Herrera,
  • Rosa Maria Vivanco-Hidalgo

摘要

This paper presents the AQuAS AI Assessment Guide, a methodological framework developed to support the evaluation of digital health technologies (DHTs) that incorporate artificial intelligence (AI). Designed collaboratively by the Agency for Health Quality and Assessment of Catalonia (AQuAS) and the TIC Salut Social Foundation, the guide defines 13 assessment domains encompassing clinical relevance, technical performance, ethical considerations, regulatory compliance, and broader system and societal impact. The guide aims to foster a robust, evidence-based and context-sensitive evaluation of AI solutions across different stages of development and diverse use cases. This article outlines the background, development methodology, and structural composition of the guide, and discusses its potential uses and contributions to responsible innovation in health systems.