Regulatory Aspects of the Use of Artificial Intelligence Medical Software

The rapidly evolving scenario of Artificial intelligence (AI) in medicine comes with new regulatory challenges, including certification, ownership, and control of data sharing, privacy protection, and accountability. The Medical Physicists (MPs) are traditionally responsible for ensuring the safety and quality of technology implementation in diagnostic and therapeutic settings. As such, they are also expected to contribute to the introduction of AI medical devices in routine clinical practice. Specifically, the MPs will play a stakeholder role for AI tools procurement, acceptance testing, commissioning, and quality assurance to confirm the claimed performances in relation to the medical device's intended use. Moreover, MPs who act as co-creators of such AI tools, will play a pivotal role in product requirements definition, data collection and annotation, clinical evaluation, support for regulatory pathways and marketing through scientific congresses and scientific publications. As AI software differs from the traditional (hardware) medical device that the MP is used to introduce in clinical settings, there is a need to acquire new competencies in the field of AI and its regulatory aspects. The purpose of this paper is to provide MPs with practical guidelines on regulatory aspects of AI medical devices, in the European and in the US landscape.