A large number of digital solutions are now used in day-to-day care. However, some digital solutions for professional use do not fall within the existing evaluation frameworks for reimbursement by national solidarity. As a result,healthcare professionals may use digital medical devices (DMDs) as part of a medical act without being fully informed about their performance or limitations, or, conversely, be reluctant to use them for these very reasons.

The HAS has been asked to initiate a reflection on MNDs for professional use, in particular on the specifics of their evaluation, to inform the choices of healthcare professionals and facilities.

After drawing up, in 2022, an inventory of the integration of professional-use MNDs into practice, the HAS is publishing a guide to help with choice for healthcare professionals (self-employed or working in healthcare facilities), networks and hospital purchasing groups. This guide aims to help professionals and purchasing organizations select the right tools, by listing the key questions to ask before purchasing. It is not intended to provide specific answers for evaluating a particular MND or establishing a score.

What MNDs are covered by this work?
These are:

• digital technologies with a CE mark;
• used by healthcare professionals;
• and which are not eligible for a national evaluation process.

The scope targeted is thus concentrated on DMNs for screening assistance, diagnostic assistance, medical decision support and therapeutic decision support (excluding software for prescription and dispensing assistance, for which work has been carried out by the HAS), as the DMNs targeted may combine several functionalities. Remote monitoring DMNs, which may be covered by ordinary law, do not fall within the scope of this work.

Towards an evaluation of these digital solutions?

The HAS is continuing its work to help build a trust framework dedicated to DMNs for professional use, according to needs. Other productions will follow, depending on the needs that are identified in terms of the evolution of the evaluation of this type of technology. In particular, thoughts on evaluation could be tested as part of experiments or national plans.