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

Authors
  • Zinchenko, Victoria
  • Chetverikov, Sergey
  • Akhmad, Ekaterina
  • Arzamasov, Kirill
  • Vladzymyrskyy, Anton
  • Andreychenko, Anna
  • Morozov, Sergey
Type
Published Article
Journal
International Journal of Computer Assisted Radiology and Surgery
Publisher
Springer-Verlag
Publication Date
Jun 13, 2022
Pages
1–9
Identifiers
DOI: 10.1007/s11548-022-02669-1
PMID: 35691995
PMCID: PMC9188918
Source
PubMed Central
Keywords
Disciplines
  • Short Communication
License
Unknown

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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