On the issue of ethical aspects of the artificial intelligence systems implementation in healthcare

Abstract

This article aimed to analyze the ethical issues associated with different stages in the life-cycle of artificial intelligence (AI) systems and provide up-to-date information about global and domestic trends in this subject. Described herein are the international and national experiences with ethical issues of AI systems used in healthcare. In addition, the international and national strategies for the development of AI in healthcare are analyzed, with a focus on national develop-ment. Moreover, the main trends, similarities, and differences between strategies are identified. Furthermore, the ethical components of the clinical trial process are described to evaluate the safety and efficacy of AI systems in Russia. Domestic, state-of-the-art, and globally unique experience in the technical regulation of AI systems is shown on unification papers and standardization of requirements for the development, testing, and operation of AI systems in healthcare are presented; finally, the unparalleled Russian experience in certification requirements for AI-based medical devices is demonstrated. Furthermore, the article summarizes the main conclusions and emphasizes the importance of a strong successful health-care system based on AI technologies that build trust and compliance with ethical standards.