Currently, systems based on artificial intelligence (AI) are finding increasing application in medicine. Acting as assistants of both the attending physician and managing physician, they can be a good help in solving a number of problems in modern healthcare, such as staff shortage, professional burnout and, in some cases, insufficient staff qualification. However, this leads to increased requirements for reliability of such systems. Introduction of a new advanced technology raises a number of ethical issues and problems, the solution of which is necessary to gain trust of people and reduce distrust associated with the use of AI technologies. It seems that if ethical standards determine and set the progressive development of artificial intelligence, this will lead to the maximum benefit from the use of this technology in healthcare. The paper examines the ethical aspects of transition of software into the category of medical devices. At the same time, legal and organizational mechanisms for solving ethical problems at both the international and domestic levels are provided. The activities of both public and government organizations in this field are considered. The need to obtain the permission of ethical committees for conducting clinical trials and ensuring informed consent of patients is emphasized. It also highlights the importance of integrating medical data into structured datasets that can be registered as databases. This will contribute to improved quality of medical research and practice.