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Bakul Patel

Sr Director, Global Digital Health Strategy & Regulatory; Former Chief Digital Health Officer and Founding Director of the Digital Health Center of Excellence at US FDA

Bakul Patel is a renowned figure in the digital health industry, having served as the Former Chief Digital Health Officer at the US Food and Drug Administration (FDA). He was also the Founding Director for the Digital Health Center of Excellence at the FDA, where he made significant contributions to the field. Patel is credited with creating the widely accepted term 'Software as a Medical Device (SaMD), setting the foundation for global regulatory frameworks.

As the Chair of the SaMD working group at the International Medical Device Regulators Forum (IMDRF), Bakul Patel authored crucial documents that established harmonized regulatory standards for SaMD. His work has had a profound impact, with regulatory bodies in the EU, Japan, Canada, Brazil, Australia, and the USA adopting the concepts and principles he developed.

Bakul Patel is the architect and inventor of the FDA’s innovative 'Digital Health Software Precertification (Pre-Cert) Program,' which revolutionized the regulatory oversight of medical device software. His expertise extends to the framework for Artificial Intelligence/Machine Learning (AI/ML)-based software, including a predetermined change control concept that enhances efficiency and compliance.

Recognized as a visionary leader and digital health strategist, Bakul Patel has a proven track record of anticipating industry trends and spearheading organizations towards sustainable growth. He has played a pivotal role in shaping national and international public health policies, particularly in the realm of digital health technology. Patel has been instrumental in establishing the necessary organizational infrastructure for digital health initiatives at the FDA.

In addition to his role at the FDA, Bakul Patel has held key positions at notable organizations such as Google, where he served as the Senior Director of Global Digital Health Strategy & Regulatory. His educational background includes an MBA in International Business from The Johns Hopkins University, an MSc in Electronic Systems Engineering from the University of Regina, and a Bachelor's degree in Electronics and Communications from Karnatak University.

All opinions shared by Bakul Patel on LinkedIn are his own, reflecting his expertise and insights in the digital health sector.

Bakul Patel
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Location

Washington DC-Baltimore Area