Moscow radiologists develop 10 Federal Standards for testing artificial intelligence in medicine

Moscow specialists have developed new standards that establish general requirements for AI systems and quality management systems in medicine. The adopted standards will be beneficial in the development of new algorithms and testing of existing ones. It will also ensure that only best practices are brought into practical medicine. The new GOST R came into force on January 1, 2023; so today their total number has already reached 10.
Nowadays, people are witnessing a major breakthrough in the field of artificial intelligence. The first federal standards (GOST R) for testing Artificial Intelligence in clinical medicine were published last year and new requirements became effective in January. Thus, 10 GOSTs R have already been adopted and applied today. Specialists are engaged in developing standards, relying on its unique experience and scientific research. This will build confidence and trust in artificial intelligence and the technology will be more transparent at the early stage, during registration and operation. This enables to implement smart solutions even faster, as well as get better and more predictable tools for patient health.
First of all, GOST are earmarked for developers of artificial intelligence services, laboratories in technical testing and medical companies in clinical trials.
New standards establish the general specifications of federal standards “Artificial Intelligence Systems in Clinical Medicine”. In addition, they will determine the requirements for testing methods for the analysis of medical images. GOST R 59921.8-2022 will provide enterprises with instructions on applying GOST ISO 13485 to the procedures related to ordering, supplying, developing, and managing AIS. GOST R 59921.9-2022 applies to data mining obtained by research methods in clinical physiology. It determines the organization of work on the standardization of testing algorithms and AIS used for data processing and analysis.
The initiative to create national standards for the introduction of artificial intelligence systems in medicine belongs to the subcommittee 01 of the Technical Committee for Standardization 164 “Artificial Intelligence”, organized on the basis of the Center for Diagnostics and Telemedicine of the Moscow Health Department. To develop common concepts and norms for all participants in the process, the capital brought together several dozen specialists – software developers, doctors, professors, and researchers.
Today, more than 40 artificial intelligence services have been introduced in medicine in 17 different modalities. Doctors use AI to sort fluorography, mammography, radiography, computed tomography and magnetic resonance imaging. Artificial intelligence aids in finding symptoms of lung cancer, COVID-19, osteoporosis, aortic aneurysm, coronary heart disease, stroke, pulmonary hypertension, hydrothorax, as well as breast cancer, flat feet and on images. The project is being implemented by the Moscow Social Development Complex in cooperation with Moscow Department of Information Technologies. The Center for Diagnostics and Telemedicine of the Department of Health of Moscow has become a platform for the development of artificial intelligence technologies in Russian radiation diagnostics,
Briefly on the Diagnostics and Telemedicine Center: Diagnostics and Telemedicine Center was established in 1996. It is a top scientific and telemedicine organization under the Moscow Health Department. It specializes in AI implementation in medicine, research, imaging diagnostics, radiology departments in medical organizations, including the telemedicine approach.