Development of the methodological framework for the evaluation of digital health technologies in Spain

The Ministry of Health has commissioned the Agency for Health Quality and Assessment of Catalonia (AQuAS) to develop, with the collaboration of the various agencies that make up the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS), a specific methodological framework for the evaluation of digital health technologies that would allow a comprehensive assessment of this type of technology. This methodological framework, explicitly developed for the evaluation of digital health technologies, is designed to be used in technologies that are mainly in the post-authorization phase of the market and focuses on:

• Describing the domains, dimensions, and sub-dimensions to be considered in the evaluation of digital health technologies, with a particular focus on non-face-to-face care models, mobile health (mHealth), and artificial intelligence (AI);
• Defining the standards of evidence that digital health technologies must achieve according to the classification of the risk derived from their use.

It should be noted that the framework is intended to be used together with regulatory requirements and does not constitute or replace, in any case, existing regulatory processes.

Target users of the methodological framework include technical staff of health technology evaluation agencies, research staff and developers of digital health technologies, innovation centers, healthcare professionals and service providers, decision-makers, and regulatory bodies.

The methodological framework is in the final phase of development.

The full details in Spanish can be found here and here.

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