Legal regulation of artificial intelligence software in healthcare in the Russian Federation

Abstract: Artificial intelligence (AI) technologies are being actively developed in modern healthcare. Despite the extensive data on the pros-pects for AI, promises of the developers of such products are inflated sometimes. As a result, overestimated expectations of AIcan occur in practical healthcare. There are many obstacles for the widespread adoption of AI in practical healthcare. In this re-gard, a balance between creating the conditions for accelerated introduction of AI and ensuring the reasonable control of po-tential risks of harm to patients’ health is an urgent task of modern regulation of software as medical devices (SaMD) in Russia. The Russian Federation has recently conducted a consistent improvement of the current legislation to ensure state control over safety and effectiveness of SaMD. Decree of the President of Russia dated by October 10, 2019 No. 490 approved the Russian national strategy for the development of AI up to 2030 and identified healthcare as one of the key areas for the development and implementation of AI. The concept of regulation of AI and robotics up to 2024 was approved. The criteria for classifying soft-ware as a medical device were introduced. In accordance with the IMDRF methodological guidelines, the classes of potential riskfor the use of SaMD, including ones created using AI technologies, were defined. The requirements for technical and operation-al documentation for SaMD, as well as the requirements for technical and clinical trials of SaMD were clarified. A simplified one-stage procedure for state registration of SaMD was introduced. The rules of post-registration monitoring were determined. In this manuscript, the authors analyze the current regulatory requirements for SaMD.