Subcommittee “Artificial Intelligence in Healthcare” (PK01/TK164)

In 2019, the Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department established a subcommittee “Artificial Intelligence in Healthcare” (PK01/TK164) (Order of the Federal Agency for Technical Regulation and Metrology dated December 31, 2019 No. 3471) subordinate to the technical committee on standardization “Artificial intelligence” (TK 164). PK01/TK164 was created to develop strategies, procedures, and rules related to the standardization issues delegated to PK01/TK164. These include activities that cover regional, national, interstate and international standardization in compliance with the applicable legislation.

Collaboration between the PK01/TK164 participants is carried out on a voluntary basis.

Main tasks of the SC-01

At the national level

Establishment of a program for developing national standards, including a review of existing standards in the Russian Federation to determine whether they should be updated or repealed, and consideration of proposals for application of international and other standards at the national level


Conducting scientific, technical, legal and regulatory reviews of draft standards and amendments to them, as well as an expertise of official translations of international and other standards into Russian


Assessment of the feasibility of approving standards assigned to the SC 01


Development of national standards

At the international level

Participation in the SC 42 “Artificial Intelligence” of the ISO/IEC Joint Technical Committee (JTC 1) for Information Technology, as well as other relevant international technical committees;


Elaboration of the position of the Russian Federation on voting on international draft standards; 


Preparing proposals for the development of international standards, including on the basis of national standards;


Development of international standards (ISO).

Main standards under development

General requirements

Clinical and technical trials (2 GOST R state standards).
Evaluation and control of parameters, adaptive algorithms, general requirements, life cycle processes (4 GOST R state standards).
Glossary of terms, classification, QMS, risk management system, ethical aspects (5 GOST R state standards)


General provisions (1 GOST R state standard)
The development is planned for 2022

Functional diagnostics

General provisions (1 GOST R state standard)
AI systems for diagnostic data quality control (1 GOST R state standard)
AI systems for monitoring and optimization of radiology report parameters (1 GOST R state standard)

Distant monitoring systems

General requirements (1 GOST R state standard).
Distant monitoring of physiological functions. Requirements for processing, storage and interpretation (1 GOST R state standard).
Distant monitoring of anthropometric data, motor activity of patients, severity of pain and degree of functional limitations (1 GOST R state standard).


Classification, triage and differential analysis of tissue and fluid samples (1 GOST R state standard)

CDSS in healthcare

General provisions (1 GOST R state standard)

Big data in healthcare

General requirements. Output format for the analysis and forecast (3 GOST R state standards).
Requirements for the transfer and storage of algorithm results (1 GOST R state standard)

Analytics and forecasting

General provisions (1 GOST R state standard).
Patient flow routing and optimization (1 GOST R state standard).
Analytics for patient segmentation and profiling (1 GOST R state standard)

Educational programs in healthcare

Development of digital educational platforms (simulators) for learning practical skills in clinical disciplines (1 GOST R state standard)

Image reconstruction

Application of artificial intelligence algorithms for image reconstruction.
General provisions (1 GOST R state standard)

Metrological standards

13 GOST R state standards