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.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
