Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies.

Journal: Sovremennye tekhnologii v meditsine
PMID:

Abstract

UNLABELLED: was to develop a methodology for conducting post-registration clinical monitoring of software as a medical device based on artificial intelligence technologies (SaMD-AI).

Authors

  • V V Zinchenko
    Head of the Clinical and Technical Trials Sector, Department of Innovative Technologies; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • K M Arzamasov
    Head of the Department of Medical Informatics, Radiomics and Radiogenomics; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • S F Chetverikov
    Engineer, Sector of the Development of Systems for the Implementation of Medical Intelligent Technologies, Department of Medical Informatics, Radiomics and Radiogenomics; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • A V Maltsev
    Senior Researcher, Sector of Clinical and Technical Trials, Department of Innovative Technologies; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • V P Novik
    Researcher, Sector of the Development of Systems for the Implementation of Medical Intelligent Technologies, Department of Medical Informatics, Radiomics and Radiogenomics; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • E S Akhmad
    Researcher, Sector of Clinical and Technical Trials, Department of Innovative Technologies; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • D E Sharova
    Deputy Head of the Department of Innovative Technologies; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • A E Andreychenko
    Leading Researcher, Department of Medical Informatics, Radiomics and Radiogenomics; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • A V Vladzymyrskyy
    Deputy Director for Science; Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Bldg 1, 24 Petrovka St., Moscow, 127051, Russia.
  • S P Morozov
    Research and Practical Clinical Center of Diagnostics and Telemedicine Technologies, Department of Health Care of Moscow, Moscow, Russia.