Russia develops its first national standard for AI in clinical medicine

Experts from the Center for Diagnostics and Telemedicine, together with Subcommittee PK01/TK164 «Artificial Intelligence», part of RVC’s Technical Committee 164 (TK164), have developed a draft of Russia’s first national GOST R standard to regulate clinical trials of AI systems in healthcare. The first draft of the GOST R standard has appeared on the Rosstandart website.

The development of the first draft of the national standard «Artificial Intelligence (AI) — Software testing of AI medical devices — Part 1: Clinical evaluation» had taken five months and was done by a team of experts from the Center for Diagnostics and Telemedicine together with the expert subcommittee TK164 «AI in Healthcare». The subcommittee includes leading specialists from Rozzdravnadzor, FGBU «VNIIIMT» of Rozzdravnadzor, Skolkovo Foundation, Neuromed Ltd, Medicine and Telesystems Ltd, S.K.A.T. Ltd, FGBU «N.N. Petrov Center for Oncology Research» of the Ministry of Health, Meditsinaobomne Ltd, Government of Russia’s University of Finance, MFTI University, TsNIIOZ, GBU «NIIOZMM DZM», NPO «National Agency for Telemedicine», SamGMU and other entities.

AI-based technologies are increasingly present in people’s daily lives. For intelligent systems that may incur fatalities and economic loss, there must be developed criteria that ensure the safety of AI-based systems and their effectiveness in real-world scenarios. It especially applies to AI systems employed in healthcare and clinical medicine.

GOST R «Artificial Intelligence (AI) — Software testing of AI medical devices — Part 1: Clinical evaluation» will regulate the methodological foundation of the clinical trial process, the trial procedures, correctness indices, audit, and quality control of intelligent medical systems. During the public hearing phase that will end in October 2020, interested parties may introduce amendments, suggestions, and comments to the standard.

Based on the national standard, the team of the Center for Diagnostics and Telemedicine headed by Sergey Morozov, with support from Rosstandart and TK164 and within the larger framework of ISO, has initiated the development of an international standard «Artificial Intelligence (AI) — Software testing of AI medical devices — Part 1: Clinical evaluation». The initiative to develop a standard will be reviewed by the participating member countries of the ISO subcommittee SC 42 «Artificial Intelligence» during the plenary session in October 2020.

«The national standards that we are developing together with the experts from PK01/TK164 will regulate key aspects of employing AI in healthcare and its role in making clinical decisions. Intelligent systems are designed to optimize the work of diagnosticians, automate the routine, provide information support, and implement other features that help doctors. Without the common technical norms and standards, approved by the professional community based on consensus, it is impossible to implement AI in healthcare,» says Sergey Morozov, head of PK01/TK164, director of the Center for Diagnostics and Telemedicine.

At the moment, PK01/TK164 is in the process of developing the following foundational standards:

«Artificial Intelligence (AI) — Software testing of AI medical devices — Part 2. Programs and procedures of technical evaluation»;

«Artificial Intelligence (AI) — Software testing of AI medical devices — Part 3. Application of quality management to self-learning algorithms. Algorithm modification protocol»;

«Artificial Intelligence (AI) — Software testing of AI medical devices — Part 4. Evaluation and control of operational parameters»;

«Artificial Intelligence (AI) — Software testing of AI medical devices — Part 6. Common operational requirements»;

«Artificial Intelligence (AI) — Software testing of AI medical devices — Part 7. Lifecycle processes».

The finalization of the first draft of the standard «Artificial Intelligence (AI) — Software testing of AI medical devices — Part 5. Требования к структуре и порядку применения набора данных для обучения и тестирования алгоритмов» is scheduled for September 2020.

TK164 «Artificial Intelligence» had been created with assistance from RVC in 2019 to develop a common regulatory and technical framework in artificial intelligence and promote Russian standards internationally. The December 2019 decree of Rosstandart had created subcommittee PK01/TK164 «AI in healthcare» based on the Center for Diagnostics and Telemedicine. Its role is to develop quality requirements for intelligent technologies and standards for clinical evaluations of AI-based medical software.

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