An Overview of Continuous Learning Artificial Intelligence-Enabled Medical Devices


Project Status:
Project Line:
Horizon Scan
Project Sub Line:
Emerging Health Technologies
Project Number:

This report provides an overview of continuous learning artificial intelligence (AI) as a medical device or as part of a medical device, including what they are, how they might be used, their benefits, and the potential challenges and opportunities they pose for regulation, assessment, and evaluation. Continuous learning AI 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 continue to be anticipated in this space.