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

Int J Comput Assist Radiol Surg. 2022 Oct;17(10):1969-1977. doi: 10.1007/s11548-022-02669-1. Epub 2022 Jun 13.


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.

Keywords: Artificial intelligence; Changes; Medical software based on artificial intelligence technologies; Modifications; Software as a medical device; Validation.

MeSH terms

  • Artificial Intelligence*
  • Humans
  • Software*