System Design Panel - Panelists
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) andthe Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairsthe International Medical Device Regulators Forum (IMDRF) “software as a medicaldevice” working group, a global harmonization effort. Read more..
Dr. Emad Rizk
Emad Rizk, M.D., President and Chief Executive Officer, Cotiviti
Dr. Emad Rizk joined Cotiviti in August 2016 and serves as President and Chief Executive Officer. A seasoned and renowned healthcare industry senior executive, Dr. Rizk brings to this role more than 25 years of experience working closely with payers, providers, and government entities. Most recently, he served as CEO of Accretive Health and was also a member of its Board of Directors. Prior to Accretive Health, Dr. Rizk was President of McKesson Health Solutions, a business that provides clinical and financial solutions to healthcare payers. Read more.
Esther Abels, MSc, VP Regulatory&Clinical Affairs and Strategic Business Development, PathAI
She graduated in Biomedical Health Science, toxicology. Experienced in clinical validation studies used for regulatory purposes in USA, Europe and Asia. Has a background in bridging R&D, Proof of Concept and socio economics studies. Was Clinical Research Scientist and Global Clinical Trial Manager for pivotal regulatory studies in both pharma and biotech. Worked and lived in NL as well as USA prior to relocating to Boston USA to join PathAI in 2018. She played a crucial role in the Digital Pathology Association (DPA) Regulatory and standards Taskforce and FDA collaborations. The successful outcome was that WSI for primary diagnosis was recommended to become a class II instead of class III device in the United States. Read More.
Tara Grabowsky, M.D., Chief Medical Officer, HVH Precision Analytics
System Design Panel -Moderator
Cliff Cavanaugh, Founder and Chief Technology Officer, Healthjump
Cliff Cavanaugh is a developer turned executive who has been working exclusively on healthcare tech since 2005. He has created custom software products for all sizes of medical institutions including large hospital systems to small private practices. He has pioneered several visionary solutions in the healthcare space including analytics products, cost-saving SaaS as well as robust client-server software. Currently, he is Founder and CTO of Healthjump, a company with the mission of making the health data available to all members of the care continuum. Cliff also co-founded DataTrade Solutions, a provider of Health IT services to thousands of providers via health systems and practices across the U.S.; DataTrade Solutions was sold in 2015. Read more..