The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems
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.
Authors
- Stephan Buch (ORCID: https://orcid.org/0000-0003-2928-015X)
- Max Ostermann (ORCID: https://orcid.org/0009-0004-7808-2701)
- Susan P. Gilbert (ORCID: https://orcid.org/0000-0002-7823-3774)
- Oscar Freyer (ORCID: https://orcid.org/0000-0003-3323-2492)
- Rebecca Mathias (ORCID: https://orcid.org/0000-0002-3906-2415)
- Anett Schönfelder (ORCID: https://orcid.org/0009-0007-7064-1611)
- Akira-Sebastian Poncette
- Henry Orlovsky
- Adel Bassily-Marcus
- Hannah Sophie Muti
Institutions
- German Cancer Research Center (DE)
- Heidelberg University (DE)
- Helmholtz-Zentrum Dresden-Rossendorf (DE)
- Humboldt-Universität zu Berlin (DE)
- Fresenius (Germany) (DE)
- Yale New Haven Health System (US)
- University Hospital Carl Gustav Carus (DE)
- Freie Universität Berlin (DE)
- Technische Universität Dresden (DE)
- Charité - Universitätsmedizin Berlin (DE)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2026-03-21
- DOI
- https://doi.org/10.1038/s41746-026-02535-3
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 0.00