He is the world’s foremost leader in Digital Health & has played a key role in shaping the domain. He pioneered and coined the term ‘SaMD’, risk framework for medical device regulators globally, software pre-cert pilot program, framework for (AI/ML)-Based Software. Mr. Patel was the Founding Director for the Digital Health Center of Excellence at the US-FDA, Fmr Chief Digital Health Officer- Global Strategy and Innovation at US-FDA. Currently, the Senior Director, Global Digital Health Strategy & Regulatory Health @Google
Mr. Bakul Patel
