An Overview of Continuous Learning Artificial Intelligence-Enabled Medical Devices

Abstract


 Continuous learning artificial intelligence as a medical device or as part of a medical device is a rapidly developing area – both in terms of technology development and determining how to regulate and evaluate these technologies.
 As of the writing of this report, no medical device enabled with continuous learning artificial intelligence has been authorized in Canada.
 Continuous learning artificial intelligence for health care may have a cascading effect on national and international level, including reshaping and shifting the role of regulators and health technology assessment agencies. The body of literature on the regulation, HTA, and ethical, social, and legal issues relating to the regulation and assessment of continuous learning AI is growing and changes can continue to be anticipated in this space.