On October 14, 2020, the French National Authority for Health (HAS) announced the ongoing update of the submission file guides to support companies who requested reimbursement for medical devices with a system of machine learning (artificial intelligence).
There are two abilities to receive reimbursement for medical devices with artificial intelligence - LPPR list and innovation package (Forfait innovation). In order to receive the reimbursement under one of these schemes, the manufacturer submits an application to HAS. The two guides for the application submission process are available, which will include specific information concerning the features of this type of technology to help manufacturers precisely describe the elements necessary for the evaluation. The guides explain all the key points which should be specified for technology (a type of learning, frequency of relearning, place given to human intervention in this process, etc.). The process of updating is ongoing and is planned to be finalized in January 2020.
The next step for the HAS will be the publication of a functional classification grid of digital solutions according to their purpose of use (screening, diagnostic function, prevention aid, help in understanding hygiene and dietetic measures, etc.). This grid was submitted for public consultation from April to June 2020 and should be finalized by the end of the year.
The full details in French can be found here.
See the updated LPPR guide here.
See the updated innovation package guide here.
This news is just one of about 300 market access news collected by our team in the subscription services “HTA Alerts” and “Reimbursement Alerts” every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).