E-health: the HAS publishes a reference on remote monitoring of patients with implantable cardiac prostheses

Regulations

14/04/2022

The HAS is continuing its work on remote medical monitoring and has published a reference document on remote medical monitoring of patients with implantable cardiac prostheses for therapeutic purposes. These referentials enable manufacturers and healthcare professionals to prepare for the perennial framework.

Remote medical monitoring: guidelines for each chronic disease

After being the subject of experimentation between 2014 and 2021, telemonitoring will be generalized by July 1, 2022 at the latest. In January, the HAS published 4 guidelines for telemonitoring solutions: one guideline for 4 of the 5 pathologies targeted by the experimentation program.

In March, it finalized its work with a 5e référentiel: télésurveillance médicale du patient porteur de prothèse cardiaque implantable à visée thérapeutique (défibrillateurs automatiques implantables et stimulateurs cardiaques implantables).
The aim of this work is to help manufacturers and healthcare professionals prepare for the perennial framework by being aware of the requirements - technical and organizational, retained by the national commission for the evaluation of medical devices and health technologies (CNEDiMTS).

These guidelines cover all the elements required for telemonitoring, in line with the scope set out in Article 36 of the LFSS, namely the minimum requirements applicable to the telemonitoring operator and the technical requirements for the MND and the necessary collection accessories.

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