HAS defines a roadmap for methodology for evaluating connected medical devices
The French National Health Authority (HAS) has recently published a document which defines a roadmap for identification of the specificities of appraisal and evaluation of connected medical devices (CMDs). The clinical and economic value of these technologies is frequently the object of evaluation at HAS for brand-specific or generic registration in the LPPR list. With this new methodological review, HAS acknowledges the fact that CMDs might have peculiarities in terms of organizational impact, mode of action and effect on patients’ quality of life and that these specificities might entail differences in the methodology of appraisal and evaluation of the value of the technology.
CMD are intended as technologies used for telemonitoring and teleconsultation purposes, or able to generate a patient action for the purpose of self-treatment or self-monitoring.
In order to define clear instructions on the methodology for evaluation and evidence submission for CMD, HAS will perform a systematic review of evidence published in the last 5 years, will analyse current experiences and requirements for these products in other countries, and will review databases of clinical studies and protocols for remote monitoring devices. In doing this, the multidisciplinary working group at HAS will take into consideration comments and opinions of industry representatives (including manufacturers and distributors), of relevant medical societies, of patients’ associations and of providers of services for home-based equipment, specialized in e-health, where applicable.