Standardization in regulating artificial intelligence systems in Russian healthcare

Abstract

Artificial intelligence technologies in medical practice are a promising direction in the world. Artificial intelligence medical decision support systems, diagnostic and screening programs can help medical personnel in routine and complex tasks and improve the level of medical care provided to patients. At the same time, the development, production and distribution of artificial intelligence systems must be regulated without fail. Registration and subsequent control (post-registration monitoring) of artificial intelligence systems in medicine require the creation, adjustment of the legal framework and technological regulation. The Russian Federation has developed a promising development strategy in this area. Seven national standards have been developed by experts in the field of Artificial intelligence in healthcare. These standards establish the procedures for conducting clinical and technical trials, performance requirements and the concept of life cycle, a quality management system and risk management. A separate standards is devoted to dataset creation for training and testing the developed algorithms, requirements for them and a metadata format. There are plans to bring the developed national standards to the international level, which will allow Russian manufacturers of artificial intelligence systems implemented these national standards to comply with foreign counterparts and become more competitive at the international level. The international community has already supported the development of an ISO standard based on the national standard for clinical trials. The development will be performed based on the technical committee ISO/TC 215 (Health informatics) in conjunction with ISO/IEC JTC 1/SC 42 (Artificial intelligence), this will allow bringing the national requirements for the Artificial intelligence to the international level. The cycle of these standards will summarize recognized methodologies, helping both manufacturers and medical organizations, doctors and patients to produce and use a quality, safe and effective product.

Keywords

standardization / medical artificial intelligence / artificial intelligence-based software as a medical device / medical software

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