· Sep 09, 2022

Digital medical devices for professional use

The objective of this project is to propose tools for professionals/structures and recommendations on the system to be implemented.

The aim is to:

- to support health professionals and care structures in the selection of MNDs by proposing the most appropriate and graduated approaches to help them choose, without being a brake on innovation;

- to propose to the Ministry of Health and Prevention an evaluation system for the MNDs concerned by this framework note;

At a minimum, the following will be produced:
- A summary document including: an inventory of MNDs for professional use, an analysis of the literature, the positions of the stakeholders and their methodologies for selecting these tools and a risk matrix for existing or emerging MNDs for professional use, with a view to an evaluation matrix if necessary

- A guide to help in the choice of MNDs for professional use, which will orient users and purchasers by enabling them to identify the main key questions to ask themselves or to ask about the MND.

Depending on the needs that will be identified in terms of the evolution of the evaluation of this type of technology:
- The HAS will be able to make proposals to the public authorities.

- And several practical actions and additional productions may be implemented, in particular methodological guides/referentials for this type of MND, intended for professionals or user centers and any actor wishing to carry out their evaluations.

Estimated output: Q4-2022/Q1-2023