This research proposes innovative regulatory approaches for the safe and effective integration of generative AI and large language models in healthcare settings.

• Non-deterministic outputs and broad functionalities of GenAI/LLMs challenge existing medical device regulatory frameworks
• Novel approaches are needed to address AI systems that continuously evolve and learn from real-world data
• The paper calls for global collaboration on regulatory science innovations tailored to GenAI capabilities
• Recommendations include balancing innovation with patient safety through adaptive governance models

This research is critical for the medical field as it addresses the urgent need for updated regulatory frameworks that can keep pace with rapid AI advancements while ensuring patient safety and ethical implementation in clinical settings.

Regulatory Science Innovation for Generative AI and Large Language Models in Health and Medicine: A Global Call for Action