Changes in software as a medical device based on artificial intelligence technologies.

Journal: International journal of computer assisted radiology and surgery
Published Date: Jun 13, 2022

Abstract

PURPOSE: to develop a procedure for registering changes, notifying users about changes made, unifying software as a medical device based on artificial intelligence technologies (SaMD-AI) changes, as well as requirements for testing and inspections-quality control before and after making changes.

Authors

  • Victoria Zinchenko
    The Department of Innovative Technologies, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
  • Sergey Chetverikov
    The Department of Medical Informatics, Radiomics and Radiogenomics, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
  • Ekaterina Akhmad
    The Department of Innovative Technologies, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia. e.ahmad@npcmr.ru.
  • Kirill Arzamasov
    The Department of Medical Informatics, Radiomics and Radiogenomics, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
  • Anton Vladzymyrskyy
    Deputy Director for Science, State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department", 24 Petrovka Str., Bldg. 1, 127051, Moscow, Russia.
  • Anna Andreychenko
    Department of Physics and Engineering, University of Information Technology, Mechanics and Optics, St Petersburg, Russia.
  • Sergey Morozov
    Department of Health Care of Moscow, Research and Practical Clinical Center of Diagnostics and Telemedicine Technologies, Moscow, Russia.

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