The Center for Diagnostics and Telemedicine of the Moscow Healthcare Department has developed a state standard (GOST) that regulates the conduct of clinical trials of AI systems. The standard defines the methodology and procedure, contains definitions and terms, includes indicators of effectiveness of such systems as part of their clinical validation, and contains the reporting form for the clinical part of the trials. The standard also describes the quality control of clinical trials. The results evaluation consists of three stages:

• analytical validation - confirming the ability of a neural network to process data accurately, reliably and in a retraceable way;
• assessment of conformity of the output data to the declared functionality;
• validation of the system’s effectiveness - the ability to produce clinically significant results.

The Artificial Intelligence Systems in Clinical Medicine. Part 1. Clinical Evaluation GOST was developed by the specialists of the Center for Diagnostics and Telemedicine of the Moscow Healthcare Department. The standard has been approved and will come into force on September 1, 2022.

Original in Russian