The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems.

Freyer, Oscar; Mathias, Rebecca; Muti, Hannah Sophie; Orlovsky, Henry; Buch, Stephan; Ostermann, Max; Schönfelder, Anett; Poncette, Akira-Sebastian et al. · NPJ Digit Med · 2026

expert_opinion · Level V

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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.