Integration of AI-based software as a medical device into Russian healthcare system: results of 2023

Introduction . Healthcare is one of the priority sectors for the deployment of artificial intelligence (AI) technologies worldwide, including Russia. A key area of AI deployment is the integration of AI-base software as a medical device (AI SaMD) into the Unified digital systems of the healthcare sector of the Russian Federation. Aim . Research of the results of the deployment of AI SaMD in healthcare of the Russian Federation in 2023. Materials and methods . The State Register of Medical Devices and Organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices was used as information about AI SaMD registered in Russia. As information on the deployment of AI SaMD, data from monitoring to the federal project “Creating a single digital system in healthcare” was used, including reports from constituent entities of the Russian Federation upon these activities. The results of the implementation of AI SaMD in Moscow were obtained according to data from the Moscow Department of Health as part of an experiment on the use of innovative technologies in the field of computer vision for the analysis of medical images. Results . As of January 1, 2024, Roszdravnadzor registered 26 AI SaMD, 77 % of them were developed by 13 Russian companies. At the end of 2023, 84 (94 %) constituent entities of the Russian Federation met the minimum established target for the purchase of AI SaMD. Within the framework of public procurement procedures provided by law, 106 government contracts were signed for the purchase and deployment of AI SaMD for a total amount of 448 million 430 thousand rubles. Conclusion . In 2023, the Russian healthcare system made a significant breakthrough in terms of the practical deployment of AI SaMD. Completed procurement and deployment projects are the basis for subsequent industry development.