Overview

This book presents the content of two seminars held at the university campus in Cesena (IT) on December 10 and 17, 2024, at the invitation of Prof. Cristiana Corsi. These sessions aimed to equip biomedical engineers with a thorough understanding of the European Artificial Intelligence Act and its implications for the healthcare industry and services. The seminars explored key provisions of the regulation, examined its impact on medical device development and clinical practice, and illustrated its influence through case studies on future biomedical innovations. The first seminar provided an in-depth analysis of the Artificial Intelligence Act's core provisions and their relevance to biomedical engineering. Designed specifically for professionals in the field, it offered a comprehensive overview of the regulation's implications, focusing on how these rules affect the development of medical devices and clinical workflows. The discussion emphasized the challenges and opportunities posed by integrating advanced AI technologies into biomedical applications, with particular attention to innovation, safety, and the protection of fundamental rights. Through case studies, participants examined strategies for incorporating AI solutions while adhering to the transparency and safety requirements established by the Act. The second seminar concentrated on practical compliance strategies for implementing AI projects within the biomedical sector. It detailed essential regulatory guidelines, including documentation, transparency obligations, and risk management protocols. Participants explored best practices for ensuring compliance, such as post-market surveillance and monitoring procedures critical to the deployment of AI-driven medical devices. This session also provided insights into aligning AI project development with European regulatory standards, optimizing the transition from design to market readiness.

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