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

**Authors:** Oscar Freyer, Rebecca Mathias, Hannah Sophie Muti, Henry Orlovsky, Stephan Buch, Max Ostermann, Anett Schönfelder, Akira-Sebastian Poncette, Adel Bassily-Marcus, Stephen Gilbert

PMC · DOI: 10.1038/s41746-026-02535-3 · NPJ Digital Medicine · 2026-03-21

## TL;DR

This paper discusses how AI regulation in intensive care units must evolve as AI systems become more advanced and generalist.

## Contribution

The paper introduces a five-paradigm framework to address increasing regulatory complexity in AI systems for healthcare.

## Key findings

- Current regulatory frameworks are device-centric and ill-suited for generalist AI systems.
- A new approach called agentic oversight is proposed to manage complex AI systems in healthcare.
- Regulatory complexity increases with AI functionality and scale, requiring new oversight paradigms.

## 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.

## Full-text entities

- **Diseases:** sepsis (MESH:D018805), hallucinations (MESH:D006212), AI (MESH:C538142), inflammatory (MESH:D007249), ICU (MESH:C000657744), MD (MESH:D009471)
- **Chemicals:** MDs (MESH:D008573)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

2 figures with captions in the complete paper: https://tomesphere.com/paper/PMC13022208/full.md

## References

25 references — full list in the complete paper: https://tomesphere.com/paper/PMC13022208/full.md

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Source: https://tomesphere.com/paper/PMC13022208