The National Standard certification mark assures patients that a product has undergone rigorous testing and meets safety standards. This principle now extends to medicine, particularly artificial intelligence (AI) systems that support clinicians in diagnostics and decision-making.

This development follows an initiative in Moscow, beginning with a large-scale experiment 5 years ago to integrate computer vision into radiology. The program has successfully progressed from experimental implementations to the systematic integration of AI into routine clinical practice. Throughout this evolution, the primary objective has remained consistent: to prioritize the demonstrable reliability and clinical utility of AI tools over their mere proliferation.

In medicine, AI functions not as an independent "digital doctor" but as a supportive tool used by qualified radiologists. For such tools to be safe, reproducible, and predictable, they require standardized protocols for application. National standards serve this purpose, acting as a "quality certificate" for medical AI solutions – defining best practices for development, testing, implementation, and routine clinical use.

The Center for Diagnostics and Telemedicine of the Moscow Healthcare Department, a leading scientific and practical institution, is spearheading this standardization effort. The Center not only deploys AI in healthcare settings but also creates nationwide guidelines for its safe application. It also leads the "Artificial Intelligence in Healthcare" subcommittee under Technical Committee No. 164 "Artificial Intelligence."

"It is important to regulate software quality control methods even after state registration, as well as to update the registration certificate as new versions of the software are released. Safe AI in medicine is our priority," states Yuri Vasiliev, MD, Chief Officer of Radiology at the Moscow Health Care Department and Medical Director of the Center for Diagnostics and Telemedicine.

Moscow's contributions have earned national acclaim: the Center received the "Standardizer of the Year" award in 2022 and 2025 for its practical advancements in standards with significant social impact. To date, the Diagnostics and Telemedicine Center of the Moscow Department of Healthcare has authored 28 national standards governing AI use in healthcare. Six of these took effect in early 2026. Collectively, these documents form a comprehensive, evolving regulatory framework that standardizes AI application in medicine, clarifies implementation guidelines, and establishes industry benchmarks while prioritizing patient safety.

The standardization initiative is now looking ahead. The forthcoming focus is the development of national standards for next-generation generative artificial intelligence, a field attracting significant global scientific and clinical interest. Establishing proactive guidelines in this area aims to address not only innovation but also the imperative for responsible implementation and governance.

While the creation of such a comprehensive regulatory structure for medical AI remains a complex, ongoing challenge internationally, Moscow's sustained effort has established a substantive body of work. Notably, comparable, directly equivalent documents do not yet exist within the current catalogue of the International Organization for Standardization (ISO). Consequently, this work contributes to shaping both national and international discourse on the responsible integration of AI in medicine.

The fundamental purpose of this work remains unchanged: to safeguard patient health. Through the establishment of clear standards, AI technologies are evolving into validated, reliable tools for clinicians, with regulatory oversight serving as the guarantor of their quality and safety.