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.
The accelerated method to produce guidelines results in recommendations delivered in leaflet format within a six-month period, which address a limited set of questions.
Stratified medicine is a therapeutic approach based on drug/diagnostic test associations. The objective of the diagnostic test is to use a marker predictive for the effect of the treatment in order to select the patients to whom it is administered so as to treat only the subpopulation that will benefit from it.
To address scientific and operational concerns in this area, the HAS published "Choices in methods for economic evaluation" which outlines a transparent and methodological framework, in accordance with HAS principles. This document is a working tool that serves to clarify the rules HAS sets for itself with regards to its scope of action, while providing guidance for manufacturer submission.