Legal news
Towards a change in evaluation methods for professional digital medical devices ?
Digital medical devices (hereinafter “DMD”), particularly those incorporating artificial intelligence (hereinafter “AI”) technologies, are developing rapidly in the healthcare sector. To support this development, the competent regulatory authorities are committed to assessing both the safety and efficacy of these DMD. Thus, DMD that are reimbursed by health insurance organizations are assessed both by the National Commission for the Evaluation of Medical Devices and Health Technologies (hereinafter “CNEDIMTS”) of the French National Authority for Health (Haute Autorité de Santé), and by the CNAM (French social security) directly, including with regard to the interoperability, safety and ethical guidelines set out in article L. 1470-5 of the French Public Health Code, and specified for DMD in the decree of February 22, 2023.
Today, however, the situation is different for DMD used for professional purposes. In fact, when these devices are used on a BtoB basis, such as enhanced business software or DMD used to help diagnose or screen for cancerous nodules based on X-ray images, and/or when they are not reimbursed by the health insurance scheme, they are not subject to any assessment other than CE marking. Precisely because they are used exclusively for professional purposes, these DMD are not assessed by the CNEDIMTS of the Haute Autorité de Santé, as are other DMD intended to be reimbursed by social security organizations.
Nor are they evaluated in the same way as DMD assessed by the HAS, as part of an exhaustive dossier that regularly requires additional observational studies, notably on the basis of data from the National Health Data System, to assess the effectiveness and impact of these MNDs on the care pathway.
As a result, and leaving aside the anti-competitive consequences of the obvious differences in management between the various DMD, which are equally important in terms of care, this lack of regulation prevents any in-depth analysis of the real impact of these tools on the quality of care.
This situation has given rise to discussion, notably on the part of the French health insurance system and the HAS, which consider it necessary to initiate a process of reflection to explore the possibility of evaluating DMD for professional use, in much the same way as BtoC DMD. The HAS plans to include a reflection on the evaluation of DMD intended for healthcare professionals in its strategic project, to be published in early February 2025, specifying however that a systematic evaluation of DMD for professional use would not be adapted to the number and diversity of these tools. A new approach, based on concrete experiments, could be explored.
With this in mind, an initial trial of AI-based DMD for general practitioners is scheduled to begin in mid-2025. This experiment will involve artificial intelligence tools to help interpret electrocardiograms (“ECGs”), and will enable GPs to improve the efficiency and accuracy of their diagnosis, particularly for cardiovascular pathologies. The results of this experiment, which should provide a better understanding of the impact of these tools on patient care, will serve as a basis for assessing their relevance and effectiveness in the day-to-day practice of GPs. This experimental approach could serve as a model for other DMD for healthcare professionals.
However, the SNITEM (French union of medical devices companies) believes that this new regulation would add up to an already extremely restrictive framework for the actors involved.