The rapid advancements in artificial intelligence (AI) have led to the development of sophisticated large language models (LLMs) such as GPT-4 and Bard. These LLMs have the potential to revolutionise healthcare by assisting with clinical documentation, insurance pre-authorisation, research paper summarisation, and patient communication. However, the implementation of LLMs in healthcare requires careful regulation to ensure patient safety, ethical standards, and data privacy. The newest version, GPT-4, brings advanced features like reading text on images and analysing image context. The unique characteristics of LLMs, such as their scale, complexity, broad applicability, real-time adaptation, societal impact, and data privacy concerns, necessitate a tailored approach to regulation. The FDA has made progress in regulating AI-based medical technologies but faces challenges in regulating LLMs.
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