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

Victoria Zinchenko Sergey Chetverikov Ekaterina Akhmad Kirill Arzamasov Anton V Vladzymyrskyy Anna Andreychenko Sergey Morozov

Published in: International journal of computer assisted radiology and surgery (2022)

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.

Keyphrases

artificial intelligence
machine learning
big data
deep learning
healthcare
decision making