Regulatory framework of AI/ML in the medical sector: Legal, Ethical, and Perspectives

Regulatory Framework of Artificial Intelligence and Machine Learning in Medical Sector provides a focused overview of the growing role of AI and ML in modern healthcare and the regulatory challenges associated with their use. The book discusses the fundamentals, benefits, applications, risks, and limitations of AI/ML technologies, with particular emphasis on AI/ML-enabled medical devices and Software as a Medical Device (SaMD). It examines regulatory pathways, risk classification, approval of AI/ML-based medical devices, and evolving approaches to device modifications and lifecycle management. Special attention is given to FDA regulatory approaches in the United States and CE-marking and regulatory frameworks in Europe, along with applications in healthcare, regulatory affairs, labeling, submissions, and cardiovascular imaging. The book is intended as a useful reference for students, researchers, healthcare professionals, and those interested in medical technology regulation.