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2023 - The Year of ChatGPT: Its Effects on Healthcare and FDA Regulations
(Thursday, December 14, 2023) This year was unquestionably the Year of ChatGPT. It affected all aspects of life, including healthcare and FDA-regulated products. ChatGPT did for artificial intelligence (AI), what iPhones did for smartphones 15 years ago. Although several AI-based medical products have been used in medicine and even approved by the FDA in the last few years, no other AI product caught the imagination of the general public like ChatGPT. Clearly, there are many applications of large language model generative AI in healthcare, but we also found many challenges that would limit its use in the short term and need new rules to regulate. Thousands of applications of generative AI-based or derived tools for all aspects of life have been created or proposed in the last 12 months alone. Proponents of generative AI in healthcare have been very bullish about its prospects based on its potential to quickly identify patterns in large datasets, generate human-like responses, and propose strategic plans for biomedical research and delivery of healthcare. Some applications are straightforward such as the use of generative AI in documentation, patient communication, and workflow management in medical practices. Most of these are not regulated by the FDA so their use is governed primarily by market demand. Other products are tricky such as the use of AI algorithms in diagnostic applications, clinical trials, GMP manufacturing, and drug development. However, the speed at which technical development in this field is happening is worrisome. FDA has authored several white papers on the best practices for using AI in GMP, nonclinical and clinical research, and post-market surveillance before the release of ChatGPT. However, concerns due to the very rapid rise of ChatGPT and similar programs by Google and Microsoft led the US government to release the Presidential Executive Order in October establishing new standards for AI safety and security. Efforts are underway to create appropriate guardrails for it. Most people don’t realize that this phenomenon of generative AI that can create human-like responses is only one year old. Fun fact: ChatGPT cannot even write an essay on its own rapid progress last year because it is not aware of anything that happened post early-2022. We have barely scratched the surface of its potential. There will be some setbacks such as the research that showed that ChatGPT’s tendency to hallucinate or lie when it does not know the correct answer leads to a lot of wrong answers related to drugs and diseases. But it will improve. As the dust of the initial rush settles, the year 2024 and beyond will see big changes in healthcare and FDA-regulated products, led by generative AI. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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