This is an opportunity for you to share your software development expertise with the FDA and an opportunity to ask questions to encourage smart and appropriate regulation from the FDA.
Join other Colorado startups and health IT innovators for a conference call with Dr. Jeff Shuren and Bakul Patel from the FDA.
CLICK HERE TO RSVP
The 2012 FDA Safety and Innovation Act includes a provision that Senator Michael Bennet helped craft that required the Department of Health and Human Services to develop a set of recommendations of how health IT should be regulated to promote innovation and protect patients. In April of 2014, the FDA released the draft report, "Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework." A copy of the report can be downloaded here. Comments will be accepted through July, 7, 2014 and can be submitted here.
Biographies of Speakers
Dr. Jeff Shuren, Director, Center for Devices and Radiological Health, FDA
Dr. Shuren has been the director since 2010. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He received his J.D. from the University of Michigan. http://www.fda.gov/AboutFDA/CentersOffices/ucm193990.htm
Bakul Patel, Policy Advisor in the Office of Center Director, Center for Devices and Radiological Health, FDA
Mr. Patel is responsible for advising the Center Director on regulatory issues related to Health information technology, mHealth and serving as a liaison between Federal Communications Commission and FDA. Mr. Patel currently is the co-chair of a task group at Association of Medical Instrumentation (AAMI), for developing a technical information report (TIR) that would provide recommendations for using Agile software development practices for developing medical device software. Prior to joining FDA, Mr. Patel was a senior consultant with the USDA as a Lean Six Sigma Black Belt for the modernization project for farm services agency. Mr. Patel's previous experiences include working as Senior Program Manager at EMC Corp., senior product manager, software engineering manager and as a software/systems engineer with various high technology organizations. Mr. Patel has a MS in Electrical Engineering from the University of Regina, Canada and a MBA from Johns Hopkins University, Baltimore. http://obssr.od.nih.gov/mHealth_Winter_2011/patel_bio.html