Good practice guidelines on health apps and smart devices (mobile health or mhealth)

This contribution from HAS aims to provide guidance for, promote use of and increase confidence in health apps and smart devices, by supplying good practice guidelines for manufacturers and evaluators (evaluating  bodies, consumer associations or medical professional organisations), who can use them for their own assessments.

These guidelines cover apps and smart devices that have no stated medical purpose. In other words, they apply specifically to the “grey area” of apps or smart devices that have potential effects on health but are not medical devices. Medical devices, as defined by European Directive 93/42/EEC which leads to CE marking, are excluded.

These guidelines do not replace the law or regulations concerning medical devices (as defined by European Directive 93/42/EEC which leads to CE marking), data protection or consumer protection. The good practice defined in these guidelines should be applied without prejudice to the regulations in force.

These HAS good practice guidelines are not an assessment tool for reimbursement, or a professional recommendation.

In 2021, we have realized an overview about the evolution of different approaches in the process of evaluation for apps in mHealth. A lits of quality criteria of medical content is published and will be used for referencing digital services in the digital health space (mon espace santé) and in the professional service package (bouquet de services).

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