Bakul Patel
Bakul Patel is Senior Director, Global Digital Health Strategy & Regulatory at Google, focused on building a unified digital health strategy that is aligned with evolving global regulatory needs. Mr. Patel's vision is to help realize the potential of technology and its role in democratizing access to high quality, equitable healthcare.
Prior to joining Google, Mr. Patel held the position of the Chief Digital Health Officer of Global Strategy and innovation and Founding Director for Digital Health Center of Excellence, at the US Food and Drug Administration (FDA). In these roles, he provided thought leadership and expertise, and shaped responsible regulation that balanced innovation and patient safety for digital health. Mr. Patel coined the term "Software as a Medical device" (SaMD), and authored a risk framework and playbook that is now adopted by many medical device regulators globally. He was also the architect of the software precertification pilot program and the FDA's framework for Artificial Intelligence/Machine Learning (AI/ML)-based software which created the Predetermined change control plan - novel approach for FDA.
Mr. Patel earned an MS in electronic systems engineering from the University of Regina, Canada, and an MBA in international business from The Johns Hopkins University.
Authored Publications
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Safety principles for medical summarization using generative AI
Dillon Obika
Christopher Kelly
Nicola Ding
Chris Farrance
Praney Mittal
Donny Cheung
Heather Cole-Lewis
Madeleine Elish
Nature Medicine (2024)
Preview abstract
The introduction of Generative AI, particularly large language models presents exciting opportunities for healthcare. However their novel capabilities also have the potential to introduce novel risks and hazards. This paper explores the unique safety challenges associated with LLMs in healthcare, using medical text summarization as a motivating example. Using MedLM as a case example, we propose leveraging existing standards and guidance while developing novel approaches tailored to the specific characteristics of LLMs.
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