Abstract
Today, there is growing interest in artificial intelligence (AI) in the field of digital radiology (DR). This is also due to the push that has been applied in this sector due to the pandemic. Many studies are devoted to the challenges of integration in the health domain. One of the most important challenges is that of regulations. This study conducted a narrative review of reviews on the international approach to the regulation of AI in DR. The design of the study was based on: (I) An overview on Scopus and Pubmed (II) A qualification and eligibility process based on a standardized checklist and a scoring system. The results have highlighted an international approach to the regulation of these systems classified as "software as medical devices (SaMD)" arranged into: ethical issues, international regulatory framework, and bottlenecks of the legal issues. Several recommendations emerge from the analysis. They are all based on fundamental pillars: (a) The need to overcome a differentiated approach between countries. (b) The need for greater transparency and publicity of information both for SaMDs as a whole and for the algorithms and test patterns. (c) The need for an interdisciplinary approach that avoids bias (including demographic) in algorithms and test data. (d) The need to reduce some limits/gaps of the scientific literature production that do not cover the international approach.