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. 

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.
 
Chairman of the SC 01: Sergey Morozov, MD, PhD, MPH, CIIP, Chief Regional Radiology and Instrumental Diagnostics Officer of the Moscow Healthcare Department, Ministry of Healthcare of the Russian Federation for the Central Federal District, CEO of the Center for Diagnostics and Telemedicine of the Moscow Healthcare Department.
Deputy Chairman of the SC 01: Anton Vladzimirsky, MD, PhD, Deputy Director for Research of the Center for Diagnostics and Telemedicine of the Moscow Healthcare Department.
Executive Secretary of the SC 01: Daria Sharova, Deputy Head of the Department of Innovative Technologies of the Center for Diagnostics and Telemedicine of the Moscow Healthcare Department.
 

Regulations of the SC 01
SC 01 activities and workplan for 2021
 
Subcommittee SC 01 (as of January 20, 2021):
•    Total participants – 66 
•    Principal Subcommittee Members – 46
•    External experts – 20
 
Members of the SC 01 can be:
•    legal entities: representatives of federal executive authorities, the State Atomic Energy Corporation "Rosatom", other state corporations, executive authorities of the constituent entities of the Russian Federation and municipalities, scientific organizations, including those engaged in the standardization activity, manufacturers, public consumer associations;
•    individuals: experts from non-TC member organizations to consult on draft standards under development. 

Main tasks of the SC-01:
1. 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. 
 
2. 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: 
    

Priority directions in 2021:
Development of GOST R: Artificial Intelligence Systems in Clinical Medicine.

Part 1. Clinical trials.
Part 2. Program and methodology of technical testing.
Part 3. Change management in AI systems with adaptive algorithms.
Part 4. Assessment and control of operational parameters.
Part 5. Requirements for the structure and application of a dataset for training and testing algorithms.
Part 6. General operation requirements.
Part 7. Life cycle processes.

Activities of the SC 01 in the National Standardization Program for 2020-2021


 
We invite you to participate in the work of the sub-committee:
Application to join the SC 01 for individuals 
Application to join the SC 01 for legal entities
 
Executive secretary of the SC 01: 
Sharova Daria 

E-mail: pk01@npcmr.ru