Digital medical devices for professional use

Numerous digital solutions are used in routine care today. However, their utility or relevance in relation to the existing arsenal has not always been fully determined. In particular, this is the case for certain digital solutions for professional use, which do not fall within the existing evaluation frameworks for public funding cover. Consequently, healthcare professionals often use digital med-ical devices (DMDs) as part of a medical procedure without being fully informed about their performance or limitations or, conversely, are reluctant to use them.

Hence, it is necessary to reflect on the specificities of the assessment of DMDs for professional use and, beyond that, on possible assessment approaches to inform the choices of healthcare professionals and decision-making bodies responsible for purchasing equipment. Consequently, on 8 September 2022, the HAS published the project scoping document, implemented following this referral and aimed at presenting its objectives, the intended scope and the scheduled procedure.

Objectives

In this context, the challenge is to build a framework of trust dedicated to DMDs for professional use, in order to promote the incorporation of those that are useful and innovative into the healthcare system.

This project aims to propose tools for professionals/structures and recommendations on the mechanism to be set up.

The objective is to:

• support healthcare professionals and organisations in the selection of DMDs by proposing the most appropriate scaled decision support approaches, without acting as a brake on innovation
• propose a mechanism for the assessment of the DMDs concerned to the Ministry of Health and Prevention .

Scope

DMDs for professional use include a very diverse range of tools with heterogeneous functionalities. Hence, it is necessary to define the scope of response to the referral.

This project will focus on digital technologies:

• with a medical purpose and the status of medical device;
• related to a medical procedure;
• and that are not eligible for a national assessment process.

The scope will therefore focus on DMDs designed to aid screening, diagnosis, medical decision-making or therapeutic decision-making (excluding prescribing aid/dispensing aid software), with DMDs potentially combining several functionalities.

Scheduled outputs

Among the various outputs that will be produced to address this challenge, this first summary document aims to draw up an inventory of the development of digital medical devices for professional use, their integration into clinical practice by healthcare professionals and the position of regulators and health technology assessment agencies with the respect to these tools, the expectations of professionals in terms of decision support when choosing tools and to highlight decision support opportunities that could be worked upon in the context of this project.