Artificial intelligence innovations in radiology put to the test by health system regulations

Radiology was one of the first medical sectors to be directly concerned by the arrival of devices labeled “artificial intelligence” for image processing. This evolution is largely invisible insofar as it concerns tools intended for professionals. It raises the question of the conditions of regulation of these innovations, in relation to both the existing rules of the health system and the necessary adaptations for these new technologies. Based on a survey on radiologists, the industry, and representatives of the health authorities, this article shows that this regulation is largely delegated to the players in the field. Current regulation is the product of the normative work of radiologists, who are the users of medical devices defending the conditions of their profession, and the companies that develop them and have to rely on doctors’ collaboration. The public and political debate on the regulation of AI in the health field is put second to the practical considerations encountered by the stakeholders. The latter revolve around the delimitation of the radiologists’ profession and the competition between the traditional manufacturers of imaging devices and the new entrants bringing in digital innovations.