Medical physics is a constantly evolving field of physics applied to healthcare, with the objective of ensuring safety, quality and technology implementation in diagnostic and therapeutic medicine. While Medical Physicists (MPs) have been traditionally involved in areas such as diagnostic and interventional radiology, radiation oncology and nuclear medicine, in recent years the profession evolved towards other applications, such as ultrasound imaging, magnetic resonance imaging, electrocardiography and medical informatics.1

The key roles and responsibilities of an MP have been widely recognized at the international level by the International Atomic Energy Agency,2 in the US by the American Association of Physicists in Medicine3,4 and in Europe by the “European Guidelines on the Medical Physics Expert.”5 Finally, the European Federation of Organisations for Medical Physics (EFOMP) also published a statement policy 16,6 to further elaborate on the role of the MP. Specifically, the responsibilities of the MP regarding the safe use of medical radiological or radiotherapy equipment include software devices, and therefore, Artificial Intelligence (AI) applications classified as medical devices. Indeed, in some countries, both hardware and software with an impact on diagnosis or therapy are put within the scope of the core MP's activities.7

Artificial Intelligence is, in brief, the field in computer science aiming at giving to computers and machines abilities that are perceived as requiring human intelligence, such as solving problems, making decisions, and extracting correlations from complex and extensive data, including images. Artificial Intelligence-based solutions in radiological or radiotherapy sciences that aid automated disease detection, lesions segmentation or characterization or predict the therapeutic outcome from images, to list a few, fall therefore under the responsibility of the MP. As such, the MPs are expected to play a pivotal role in the coming age of AI in medicine.8, 9, 10

In a recent survey among the MP community,11,12 the majority of respondents (88%) agreed that MPs need specific training on AI while it becomes a part of the MP curriculum. In order to meet the educational needs of the MP in this new area,13 an AI Curricular and Professional Program has recently been published.14 Among the topics identified for educating the MP on AI, the regulatory aspects of applying AI software to patient care take a central role.

The purpose of this paper is to provide the MP with practical guidelines on regulatory aspects of AI medical devices, in both the European and US landscapes.