Abstract
AbstractResearch and development in the field of artificial intelligence in Russia has been conducted for several decades. Amid a global increase in attention to this area, the Russian Federation has also developed and systematically implemented its own national strategy, which includes healthcare as a priority sector for the introduction of AI products. Government agencies in collaboration with the expert community and market are developing several key areas at once, including legal and technical regulation. Based on the IMDRF recommendations, software products created using AI technologies for application in the diagnostic and treatment process are considered in Russia as the Software as Medical Devices (SaMD). Over the last year, the Government of the Russian Federation, the Ministry of Health and Roszdravnadzor made many targeted changes to the current legislation to enable a state registration of software products based on AI technologies and their introduction to the market. More than 20 regions of the Russian Federation have launched various projects to implement AI technologies in the real clinical practice. Work is underway to create the first series of national technical standards to accelerate products’ development and create more trust from healthcare practitioners.KeywordsArtificial intelligenceSoftware as medical devicesTechnical regulationLegal regulationClinical practice
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