Abstract Artificial intelligence (AI) is increasingly explored for use in intensive care units. While most approved AI devices use narrow models, research is shifting towards generalist systems based on large language models and agentic AI. In this perspective, we propose a five-paradigm framework that shows how regulatory complexity rises with AI functionality and scale. As current regulatory frameworks are device-centric, new approaches like agentic oversight are needed for orchestrating AI systems.
Freyer et al. (Sat,) studied this question.