Update of the standard for the assessment of digital services in the mHealth sector

Digital health is a fast-growing sector that represents a genuine opportunity to improve and optimise the care of users. Thousands of apps in the field of health and wellness are currently available on download platforms, making it difficult for users to choose health apps. 

A catalogue of referenced digital services has been developed on the “Mon espace santé” (MES) platform on the initiative of the DNS and the French National Health Insurance fund for salaried workers (CNAM). These digital services, developed by public or private players, are aimed at users, patients and their carers in the fields of health, wellness and maintenance of autonomy. Referencing of a digital service in the MES service catalogue requires that it comply with referencing criteria that aim to guarantee its quality to users; it is not an assessment of its clinical or organisational value. In July 2020, with a view to this referencing, the HAS had been consulted by the DNS to draw up a list of medical content quality criteria used in the mHealth sector which was published in 2021. Following the publication of this standard, an international standard ISO 82304-2 relative to the quality and reliability of health and wellness apps was published and targets quality criteria that are at least partly of the same order as the current criteria for referencing in the MES platform.  

Comparison of the criteria with ISO 82304-2 

The comparison demonstrates stricter requirements of the 2021 HAS reference compared to the ISO standard. Besides, given the uncertainty with respect to the future of the ISO standard, which may not be renewed, and its limited appearance in the review of the scientific literature, it does not appear to be necessary to align the criteria relating to medical content quality with ISO 82304-2. Nevertheless, this work took into account the formulation of the ISO standard criteria.  

Updated HAS standard  

Based on scientific literature, exchanges with stakeholders and precedent works carried out by the HAS, five MES referencing criteria relative to medical content quality have been updated and two new criteria have been added. These updates aimed at strengthening requirements in terms of the medical content of digital services and promoting access to information enabling users to assess the quality of the digital services referenced and ensure informed use of these services.  

Outlook 

The information obtained following the exchanges with stakeholders highlighted a need to make changes to the referencing method. Therefore, the HAS therefore formulates additional recommendations: 

• personalisation of criteria relative to medical content quality 

• Adaptation of the referencing process for apps with medical device status 

• development of useful information aimed at users 

• neutrality of app content 

Methodological studies related to this regulation will need to be carried out in the future. The implementation of AI system quality control scheduled by this new regulation does not require modification of the referencing criteria.