A New FDA: A Partner for the Digital Future
Saturday, March 12
12:30PM - 1:30PM
110 E 2nd St
Some healthcare entrepreneurs describe the FDA as confusing, scary and a barrier to market. Companies often don’t know if the FDA is regulating their app, device, or software, and some don’t even know to ask until it’s too late. But the FDA is looking to change that image. With new hands-off policies designed to promote innovation and efforts to engage entrepreneurs early, the FDA is becoming a partner in bringing innovations to market while ensuring public safety. Leading this charge is Bakul Patel, Assoc. Director for Digital Health at the FDA, who will provide insights into the FDA’s current and future plans for regulating digital health and answer those questions you were afraid to ask.
Assoc Dir for Digital Health
Food and Drug Administration/Center for Devices and Radiological Health
BAKUL PATEL is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and sci...Show the rest
BAKUL PATEL is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.
Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairs the International Medical Device Regulators Forum (IMDRF) “software as a medical device” working group, a global harmonization effort.
Before joining FDA, Mr. Patel held key leadership positions working in the 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 UniversityHide the rest