Moscow doctors — employees of the Center for Diagnostics and Telemedicine of the Department of Health have developed a standard regulating the conduct of clinical trials of artificial intelligence systems. Previously, such a document did not exist. National Standard (GOST R) “Artificial intelligence systems in clinical medicine. Part 1. Clinical assessment” is approved and comes into force on September 1, 2022. This was told by Anastasia Rakova, Deputy Mayor of Moscow for Social Development.
The adopted GOST defines the methodology and procedure for conducting clinical trials of artificial intelligence systems, contains terms and definitions, includes indicators of the effectiveness of such systems within the framework of clinical validation and the recommended form of a report on the clinical component of trials, describes the quality control of the procedure for conducting clinical trials.
The clinical assessment includes three stages. First, analytical validation confirms the ability of artificial intelligence systems to process data accurately, reproducibly and reliably. Then the evaluation of the clinical relationship shows that the output data of such systems corresponds to the declared functional purpose. And finally, within the framework of clinical validation, the effectiveness of the system is confirmed — the ability to produce clinically significant results.
Earlier, national standards for the introduction of artificial intelligence systems into clinical medicine were adopted and entered into force, they were also developed by the capital’s radiologists.
Moscow has been digitalizing the healthcare system for 10 years. The basis of this process is a single digital platform, which is handled by the Moscow Social Development Complex together with the Information Technology Department. The system provides personalized patient management at all stages — from diagnosis and treatment to follow-up. Thanks to the platform, data on the health status of citizens is accumulated in a single digital circuit and is available online to both doctors and patients themselves.