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.
This news is just one of about 300 market access news collected by our team in the subscription services “HTA Alerts” and “Reimbursement Alerts” every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news).
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks). First EU issues of both newsletters are available for download free-of-charge.