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The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems
Oscar Freyer1, Rebecca Mathias2, Hannah Sophie Muti2,3,4,5
1Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany. oscar.freyer@tu-dresden.de.
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.
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