Monday, 19 September 8:30–9:30 am
Pull out your smartphone. Do medical applications appear next to your games and social media apps? The regulatory limits surrounding mobile health and the measures being taken to protect consumers is the focus of this extensive discussion. Our experts will define what applications government should regulate, who in government should regulate them and how this regulation will be enforced. A multitude of questions will be addressed, such as: what is the patient’s role in this? Who owns the data? What cybersecurity measures are required? What data should be anonymous or public, and to whom should have access to it? Join us to get answers to these questions and more, plus hear solutions to develop a regulatory plan that promotes innovation and customer safety.
Moderator: Melissa Schooley, JD, senior director, global government affairs, Medtronic Inc.Panelists: Larry Carrier, MS, head of regulatory affairs, Verily Life SciencesKathy Hibbs, JD, chief legal and regulatory officer, 23andMeFrancine
Ratner Kaufman, MD, chief medical officer and vice president of global
clinical affairs for the diabetes business, Medtronic MiniMed Inc.Bakul Patel, associate center director for digital health, CDRH, FDA
Kathy Hibbs, Esq., joined 23andMe as chief legal and regulatory officer in 2014. Hibbs brings more than 20 years of legal and management expertise in the clinical laboratory and medical device industries to 23andMe. Prior to joining 23andMe, she served as senior vice president and general counsel, responsible for the legal, regulatory and business development functions at Genomic Health Inc. She has also held related posts at Monogram Biosciences Inc., and Varian Medical Systems Inc. Hibbs is active in several industry groups including the American Clinical Laboratory Association (ACLA), the Coalition for 21st Century Medicine and the Personalized Medicine Coalition (PMC). She holds a juris doctorate from the University of California, Hastings School of Law, and a bachelor of arts in political science, from the University of California, Riverside.
Francine Kaufman, MD, was named chief medical officer and vice president
of global medical, clinical and health affairs at Medtronic in April
2009. In this role, Kaufman is the key architect of the company’s global
diabetes strategy, as well as a leading voice for multi-disciplinary
medical strategy across Medtronic.Prior to joining Medtronic in
2009, Kaufman served as director of the Comprehensive Childhood Diabetes
Center and head of the Center for Endocrinology, Diabetes and
Metabolism at Children’s Hospital Los Angeles. Kaufman is a
distinguished professor emerita of pediatrics and communications at the
Keck School of Medicine and the Annenberg School of Communications at
the University of Southern California, and an attending physician at
Children’s Hospital of Los Angeles.
Kaufman was national president of
the American Diabetes Association, 2002–2003. She was president of
Shaping America’s Health, chair of the National Diabetes Education
Program, and she served as chair of the Youth Consultative Section of
the International Diabetes Federation. In 2007, she was co-chair of the
Diabetes Work Group for the Department of Health Services of the State
of California to recommend diabetes treatment and prevention strategies
for the Medicaid population. In 2005, she was elected to membership in
the Institute of Medicine. In 2009, she was elected to membership in the
Advisory Council of the Diabetes Branch of the National Institutes of
Kaufman graduated from Northwestern University in 1972
and received her medical degree from Chicago Medical School in 1976. She
completed her residency in pediatrics and fellowship in pediatric
endocrinology at Children’s Hospital Los Angeles.
Bakul Patel is associate center director for digital health at the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA). 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.
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, 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.
Patel earned an MS in electronic systems engineering from the University of Regina, Canada, and an MBA in international business from Johns Hopkins University.
Larry Carrier is a biomedical engineer with over 25 years of experience
as a regulatory professional in the medical device industry, managing
global regulatory programs and teams for small, mid-size and large
healthcare companies. Carrier is currently head of regulatory affairs at
Verily (Google) Life Sciences LLC (Mountain View, CA) where he is
responsible for global regulatory affairs for the company’s software,
sensor and science-related projects. Prior to Verily, he was vice
president of regulatory, quality and clinical at Claret Medical, a
cardiovascular start-up, and also led regulatory affairs for Medtronic
CardioVascular’s transcatheter aortic valve and stent graft products.
Carrier is a graduate of Texas A&M University with a bachelor’s
degree in biomedical engineering and holds an MS in biomedical
engineering from the University of Texas at Austin.