<p>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.</p>

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

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

摘要

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.