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

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International Journal of Computer Assisted Radiology and Surgery Aims and scope Submit manuscript

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.

Methods

The main types of changes, divided into two groups—major and minor. Major changes imply a subsequent change of a SaMD-AI version to improve efficiency and safety, to change the functionality, and to ensure the processing of new data types. Minor changes imply those that SaMD-AI developers can make due to errors in the program code. Three types of SaMD-AI testings are proposed to use: functional testing, calibration testing or control, and technical testing.

Results

The presented approaches for validation SaMD-AI changes were introduced. The unified requirements for the request for changes and forms of their submission made this procedure understandable for SaMD-AI developers, and also adjusted the workload for the Experiment experts who checked all the changes made to SaMD-AI.

Conclusion

This article discusses the need to control changes in the module of SaMD-AI, as innovative products influencing medical decision making. It justifies the need to control a module operation of SaMD-AI after making changes. To streamline and optimize the necessary and sufficient control procedures, a systematization of possible changes in SaMD-AI and testing methods was carried out.

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Acknowledgements

A. Gusev, A. Maltsev., A. Gaidukov, D. Sharova and other members of SC01 “Artificial Intelligence in Healthcare”.

Funding

This study was funded by No. in the Unified State Information System for Accounting of Research, Development, and Technological Works (EGISU): AAAA-A21-121012290079-2 under the Program of the Moscow Healthcare Department “Scientific Support of the Capital’s Healthcare” for 2020–2022.

Author information

Authors and Affiliations

  1. 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

    Victoria Zinchenko & Ekaterina Akhmad

  2. Department of Physics and Engineering, ITMO University, Kronverkskiy Prospekt, 49, 197101, Saint Petersburg, Russia

    Anna Andreychenko

  3. 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

    Sergey Chetverikov, Kirill Arzamasov & Anna Andreychenko

  4. 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

    Anton Vladzymyrskyy

  5. Radiology, 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 Morozov

Authors
  1. Victoria Zinchenko
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  2. Sergey Chetverikov
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  3. Ekaterina Akhmad
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  4. Kirill Arzamasov
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  5. Anton Vladzymyrskyy
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  6. Anna Andreychenko
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  7. Sergey Morozov
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Contributions

Andreychenko A.E., Vladzymyrskyy A.V., and Morozov S.P. contributed to conceptualization and methodology. Chetverikov S.F. and Arzamasov K.M. performed the SAMD-AI tests. Zinchenko V.V., Chetverikov S.F., and Akhmad E.S contributed to analysis and writing—original draft preparation. Andreychenko A.E., Arzamasov K.M., Vladzymyrskyy A.V., and Morozov S.P. contributed to writing—review and editing.

Corresponding author

Correspondence to Ekaterina Akhmad.

Ethics declarations

Conflict of interest

The authors declare they have no financial interests. Morozov S.P. was an unpaid president European Society of Medical Imaging Informatics (till 2018). Morozov S.P. is an unpaid chairman of SC 01 “Artificial Intelligence in Healthcare”.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

For this type of study formal consent is not required.

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Appendices

Appendix A The list of abbreviations

CT - Computed tomography

CTT - Control and technical testing

LDCT - Low-dose computed tomography

ROC - Receiver operating characteristic

SaMD-AI - a Software as a medical device based on artificial intelligence technologies

URIS - Unified radiological information service

Appendix B Types of changes to AI services

Fig. 6
figure 6

“Changes related to input data without changes in the functional purpose of the SaMD-AI”

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Fig. 7
figure 7

“Changes in the functional purpose of the SaMD-AI”

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Fig. 8
figure 8

“Changes related to the elimination of errors and program code modifications of the SaMD-AI”

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Zinchenko, V., Chetverikov, S., Akhmad, E. et al. Changes in software as a medical device based on artificial intelligence technologies. Int J CARS 17, 1969–1977 (2022). https://doi.org/10.1007/s11548-022-02669-1

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