KevinMD September 13, 2024
Harvey Castro, MD, MBA

Generative AI is revolutionizing health care, particularly large language models (LLMs) like ChatGPT, Gemini, and Claude. The potential is immense, from advanced diagnostic tools to predictive analytics and decision-support systems. However, our regulatory landscape has not kept pace. Traditional frameworks for new drugs and devices are inadequate for the unique characteristics of generative AI.

This article outlines a comprehensive framework to effectively regulate generative AI in health care, striking a crucial balance between fostering innovation and ensuring safety and efficacy.

Key challenges and considerations

1. The evolving nature of AI models. Unlike static medical devices or drugs, generative AI models constantly evolve through continuous learning and fine-tuning. Their performance and capabilities can change rapidly as they are retrained on new...

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Topics: AI (Artificial Intelligence), Technology
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