The Regulation of Artificial Intelligence in Healthcare: An Exploratory Study

The new capabilities that emerged with artificial intelligence also target healthcare settings. Nevertheless, they carry potential benefits and challenges that need to be addressed appropriately. In this paper, we mapped the current status of scientific debate on two key regulation aspects of AI in healthcare: the objects of regulation and the affected actors. Data-related issues are the most researched, such as collection, storage, and privacy. In addition, nearly half of the papers targeted policymakers with challenges, comparative analysis, and governance models. Based on these results, we propose a scheme to organize these aspects and discuss implications for AI management, policymaking, and research in this field.