Regulatory issues for artificial intelligence in radiology

Medical applications of artificial intelligence (AI) are growing rapidly, projecting future utility in healthcare, with new significant challenges to face. In this chapter, we provide basic definitions of terms such as machine- and deep-learning, analyze the integration of AI into medicine, and summarize the present and the future applications in radiology, particularly in Radiomics and Radiogenomics. Also, we offer an overview of the state of regulation of AI in healthcare, and future strategies to make AI applications safe and useful. We analyze the issue, both legal and ethical, of accountability, and the legal framework regulating medical software and data protection. Finally, we explore the ongoing lines of investigation of AI in the field of precision medicine.