Bakul

Patel

Bakul Patel is the Senior Director, Global Digital Health Strategy & Regulatory focused on helping build a unified digital health strategy for Health@Google that is aligned with the global regulatory needs. Mr. Patel's vision for his role at Google is to help realize the potential of digital health that is poised to be a gamechanger in heralding a new era for healthcare generally. Prior to joining Google, Mr. Patel held the position of the Chief Digital Health Officer of Global Strategy and innovation and Director for Digital Health Center of Excellence, at the US Food and Drug Administration (FDA) providing thought leadership and shaping responsible regulation for this emerging field of Digital Health. He is most known for coining the term “Software as a Medical device” (SaMD) and building a risk framework for medical device regulators globally. He was also the architect of the software precertification pilot program and the framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software.