Revolutionary AI Medical Testing: Rakova Unveils Breakthrough GOST

The Best Tech Education Nominations for the 2022 Mira Awards. The Russian capital's medical specialists have developed a new national standard for clinical trials of AI systems in medicine, called GOST R "Artificial Intelligence Systems in Clinical Medicine. Part 1. Clinical Evaluation." Approved and set to take effect on September 1, 2022, this document is the first of its kind in the country. 

AI Medical Testing 

The Center for Diagnostics and Telemedicine of the Moscow Health Department was instrumental in its development, leveraging their extensive experience in utilizing AI in healthcare. The Moscow Health Department specialists were also behind the creation of unified federal standards for the use of advanced technologies in medicine earlier this year.

A national standard for clinical trials of artificial intelligence systems will appear in Russia, and Moscow doctors have developed it. Anastasia Rakova, deputy mayor of the capital for social development, spoke about this. 

Previously, such a document did not exist in the country, and now GOST R “Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation” was approved and will come into force on September 1, 2022.

Employees of the Center for Diagnostics and Telemedicine of the Moscow Health Department worked on the development of GOST. According to the deputy mayor, the capital’s specialists have gained vast experience in applying AI in healthcare: in March of this year, their developments formed the basis of unified federal standards for the use of advanced technologies in medicine, and now they are moving on to federal standards for testing AI systems.

GOST R, which comes into force on September 1, defines the methodology and procedure for conducting clinical trials of AI, contains terms and definitions, indicates the performance indicators of neurosystems as part of their clinical validation, and recommends the form of a report on the clinical part of the trials. The document also describes the quality control of the test procedure itself.

The evaluation of the results consists of three stages.

Analytical validation - it confirms the ability of a neural network to accurately, reliably and reproducibly process data. Assessment of the compliance of these data with the declared functionality.

Finally, testing the ability of AI to produce clinically relevant results (that is, clinical validation itself).

“Clinical evaluation is an important part of the AI ​​system registration process as a medical device. It reveals whether the product meets the declared characteristics: accuracy, efficiency and safety requirements, whether it carries any risks. As a result of the check, we understand that the product can be trusted,” said Yury Vasiliev, director of the Center for Diagnostics and Telemedicine.

Rakova announced the development of a new standard for testing artificial intelligence systems in medicine. GOST R “Artificial Intelligence Systems in Clinical Medicine. Part 1. Clinical Evaluation” will take effect on September 1, 2022. The standard was created by specialists from the Center for Diagnostics and Telemedicine of the Moscow Health Department and aims to ensure the accuracy, efficiency, and safety of AI systems in the medical field.

According to the deputy mayor, the standard will ensure that only the best AI developments are put into practice and that doctors from all over Russia are guided by uniform standards. This will help regulate the entire process of introducing AI into medicine.

Ilya Tyrov, deputy head of the Moscow Department of Health, mentioned that the new standard will provide a more specific assessment of AI systems as medical devices. Currently, they are registered as ordinary software, but the new regulation will change that. Moscow specialists will continue to work on developing regulatory standards for AI.