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Подкомитет "Искусственный интеллект в здравоохранении" (ПК 01/ТК164)

SC 01 is a voluntary association of authorities and interested organizations (enterprises), as well as individuals. The goal of this association is to develop a strategy, procedures, and rules in the assigned field of standardization, including the actual performance within the framework of national, interstate, regional and international standardization in the subject area in accordance with the norms of legislation.


SC 01 was established in accordance with the Order No. 3471 of the Federal Agency for Technical Regulation and Metrology of December 31, 2019 "On Amendments to the Order No. 1732 of the Federal Agency for Technical Regulation and Metrology of July 25, 2019 "On Establishment of the Technical Committee for Artificial Intelligence Standardization in Healthcare" which operates within the technical committee for "Artificial Intelligence Standardization"(TC 164) and based at the Center for Diagnostics and Telemedicine of the Moscow Healthcare Department. 

Main tasks of the SC-01

At the national level
01.

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including a review of existing standards in the Russian Federation to determine whether they should be updated or repealed, and consideration of proposals for application of international and other standards at the national level
 

02.

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

03.

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

04.

Development of national standards

At the international level
01.

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;
 

02.

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

03.

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

04.

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)

Radiology

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).

Histology

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