Researchers in Moscow say they have developed Russia's first standard for clinical trials involving artificial intelligence (AI) systems.
State standard (GOST R) "Artificial intelligence systems in clinical medicine. Part 1. Clinical evaluation," which was developed by employees at the Center for Diagnostics and Telemedicine, will become effective on 1 September 2022.
"Clinical evaluation is an important part of the procedure for registering AI systems as a medical device. It reveals whether the product meets the declared characteristics: accuracy, efficiency and safety. As a result of the test, we understand the product can be trusted," explained Yury Vasiliev, director of the Center for Diagnostics and Telemedicine.
The standard reportedly contains terms and definitions, indicators of the effectiveness of such systems as part of clinical validation, and the recommended form of a report on the clinical component of trials. Also, it describes quality control of the clinical trial procedure.
