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The standard for telemonitoring of patients with implantable cardiac devices published in France
On March 17, 2022, the French National Authority for Health (HAS) published a standard for telemonitoring of patients with implantable cardiac devices (implantable defibrillators and pacemakers). In January 2022, the HAS also published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). All these standards must be met by technologies in order to be reimbursed by the new reimbursement framework for telemonitoring, which is expected to enter into force in July 2022.
Following the experiments under the ETAPES program for telemonitoring of chronic pathologies, a reimbursement framework for medical telemonitoring is planned to enter into force on July 1, 2022. These standards define technical and organizational requirements for medical telemonitoring adopted by the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS). Each standard defines the prescription conditions for remote monitoring, minimum technical specifications required for digital medical devices, distribution conditions, terms of use, professionals involved and their qualifications, organizational aspects, minimum conditions for ensuring the quality of care, monitoring the use of medical telemonitoring.
The full details in French can be found here.
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