As of January 1, seven State Standards (GOST) and two preliminary standards for artificial intelligence (AI) in healthcare have officially come into effect. Developed and approved over the past year, these documents are intended to govern the application of neural networks in various aspects of healthcare, including organization and management, remote monitoring, predictive analytics, and clinical decision support systems, as well as ethical dispute resolution. Furthermore, the establishment of standards facilitates the development of new neural networks, enhances the development of existing algorithms, and ensures that only the most effective solutions are integrated into practical medicine.

Yuri Vasilev, the Chief Consultant for radiology of the Moscow Healthcare Department and CEO of the Centre for Diagnostics and Telemedicine, emphasized the importance of these regulations. He stated, "The development of 9 standards in a year is a remarkable achievement. Today we already have 22 such normative documents." Vasilev noted that AI technologies have been integrated into the healthcare system over the past five years, directly impacting public health and safety. The newly established standards provide clarity on general and technical requirements, common terminology, and methodologies for employing neural networks, thereby enhancing patient safety during AI implementation.

These state standards establish foundational concepts and norms essential for integrating AI technologies within medical institutions throughout Russia. They are particularly beneficial for AI developers in healthcare, clinical trial experts, and researchers.

Vasilev further addressed ongoing challenges regarding AI applications, such as accountability and operational protocols. He indicated that the Center for Diagnostics and Telemedicine would continue to develop standards while facilitating communication among stakeholders as part of the National Strategy for the Development of Artificial Intelligence up to 2030. The State Standards regulate technical and clinical trials of AI in healthcare, addressing existing concerns about trial quality. Vasilev advocated for comprehensive regulation beyond standards to ensure rigorous methods and requirements for clinical trials involving AI, including data types, volumes, methodologies, and metrics. Vasiliev emphasized the importance of establishing a mechanisms for software quality control following state registration. He also highlighted the need to ensure timely updates to registration certificates as new software versions are released.

The initiative to establish national standards for AI integration in medicine originated from Subcommittee 01 of Technical Committee for Standardization 164 'Artificial Intelligence' under Rosstandart. This initiative brought together numerous experts—including software developers, medical professionals, professors, and researchers—to create unified concepts and norms.

Pre-standards are implemented temporarily to acquire experience that will subsequently inform  the development of the future State Standards. The Center for Diagnostics and Telemedicine is recognized is as a leader in AI implementation within diagnostic imaging. It possesses unique expertise in utilizing neural networks, having conducted the largest experiment involving computer vision technologies in healthcare. Over the past four years, the Center has processed more than 13 million imaging studies.