FDA Lecture: Digital Health - Getting Ready for the Digital Future

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Abstract

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration protects and promotes public health by assuring timely patient access to high-quality, safe and effective medical technologies. The Digital Health Center of Excellence’s (DHCoE) goal is to Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. Recent activities within (DHCoE) include issuing regulatory guidance to provide clarity on medical software provisions of the 21st Century Cures legislation, launching an innovative precertification pilot to develop a new approach to digital health technology oversight, and proposing a regulatory framework for modifications to artificial intelligence/machine learning based software as a medical device. During this presentation, Mr. Patel will share some of the regulatory knowledge gaps and discuss on-going activities within DHCoE that are driven towards protecting and promoting public health using digital health technologies.

Speaker bio

Bakul Patel, MSEE, MBA

Director, Digital Health Center of Excellence; Center for Devices and Radiological Health; U.S. Food and Drug Administration

Bakul Patel is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies.

Mr. Patel, in 2013, created the term “software as a medical device” (SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD. The concepts, principles and vocabulary created in harmonized regulatory framework has been used as a foundation and adopted by medical device regulatory bodies in the European union, Japan, Canada, Brazil, Australia and in the USA by US-FDA.

Mr. Patel is currently leading the effort for the agency in developing an innovative software precertification program to reimagine a pragmatic regulatory approach for Digital health that aims for patients and providers to have timely access to safe and effective digital health products.

Prior to joining FDA, Mr. Patel held key leadership positions in several sectors including telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations. 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.