The TIC Salut Social Foundation is implementing a new evaluation framework for health apps and digital assets based on a European standard

The TIC Salut Social Foundation has integrated the European standard CEN ISO/TS 82304-2 into its reference framework for certifying digital health and social care assets. Companies wishing to have their products reviewed by the foundation will receive a seal that provides greater guarantees of quality and technological reliability thanks to this new standard. This integration means not only adding to the current Certification Service  a new layer of distinctive robustness to mobile health and social care applications, but also facilitates their promotion and use within the Catalan Health System.

This new evaluation framework [Catalan version] applies to various types of digital assets, such as mobile applications, web apps, or devices integrated into digital platforms, all aimed at improving health and social wellbeing. Based on the European certification specifications of CEN ISO/TS 82304-2, the new model ensures compliance with the minimum quality requirements set by the European Commission through a label and a product sheet that detail the quality level of each application.

Etiqueta de qualitat atorgat pel nou marc d’avaluació de la Fundació TIC Salut Social

Benefits of Obtaining the Quality Label

Obtaining the quality label and the full set of documentation associated with the new evaluation framework is a key step toward promoting the technological standardisation of health applications across Europe, as well as advancing cross-border recognition between different regions. In Catalonia, it also facilitates the adoption, promotion, and use of these applications within the Health System.

To date, the foundation has conducted several evaluations of health applications, assessing factors such as usability, the technology used, user experience satisfaction, security, and content quality. Over the coming months, all apps that receive this certification will begin to be promoted within the Catalan Health System.

Catalonia and the New Regulatory Framework

Recently, the scientific journal JMIR Publications published Integrating CEN ISO/TS 82304-2 in the Catalan Health App Assessment Framework: Comparative Case Study, led by the TIC Salut Social Foundation through Carme Pratdepàdua, Head of Digital Assets, and Berta Llebot, Project Officer for Digital Health Innovation. This study details the strategy for integrating the CEN ISO/TS 82304-2 certification into the foundation’s previous evaluation framework. It includes a comparison between the two reference models in terms of content, governance model, and functionalities.

The article highlights Catalonia’s position as a European leader in the implementation of this international standard, which aims to encourage its adoption by other health authorities across Europe. In this regard, the same journal has also published another study, Compatibility of the CEN-ISO/TS 82304-2 Health App Assessment Framework With Catalan and Italian Health Authorities’ Needs: Qualitative Interview Study, which positively assesses the compatibility of this certification with the needs of public health systems across Europe and foresees its long-term adoption by other European health authorities.