2021 Federal Wearables Summit

Marion is currently the Senior Vice President of Health Care Services and the Chief Medical Officer at Cambia Health Solutions. This company administers the Regence Blue Cross Blue Shield (BCBS) health insurance plans which span four state and serve 3.1 million members. She leads medical strategy for all of Cambia and provides executive leadership for the Regence BCBS plans. This includes medical care initiatives, quality programs, value-based care plans, utilization management, pharmacy services, provider relations, network management, payment integrity, and cost stewardship. Prior to this role, Marion was the (Career) Senior Medical Advisor in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS) in Washington, DC, which had a $1.3 trillion annual budget and insured 145 Americans. In this cross-cutting role within the agency, she reported directly to the Administrator to work on policy creation, quality, and promoting the vast expansion of telehealth during the pandemic. Marion was also involved in developing value-based payment models in the Center for Medicare and Medicaid Innovation, with special emphasis on longitudinal care for chronic conditions that often are treated with surgery. Before joining CMS, she held senior leadership roles at several large medical centers. Marion has previously served as the Chair of the Indiana University Health Physician Board. She has been a physician executive in two large medical groups where she served as the Physician Executive of Surgical Services and as the Vice President of Finance. She has also been the Chair of two surgical departments and was Surgeon-in-Chief at a medical center. Marion has served as President of two national professional medical societies. Marion is a trained head and neck surgeon with advanced microvascular surgery training. She received her medical degree from Rush Medical College. Her residency training was at Johns Hopkins Hospital. Her MBA is from the Duke University Fuqua Business School with a Concentration in Healthcare Management.

Jennifer C. Goldsack co-founded and serves as the Executive Director of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine. Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Dr. Tiffani Bailey Lash serves as a Health Scientist Administrator for the National Institutes of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH). Dr. Lash is the Program Director for the NIH Rapid Acceleration of Diagnostics (RADx℠) Tech and Advanced Technology Platforms initiative, NIH Technology Accelerator Challenge (NTAC), and the NIBIB Point of Care Technologies Research Network. She also serves as co-coordinator for the NIH Common Fund's Harnessing Data Science for Health Discovery and Innovation in Africa. Her research portfolio includes Point of Care Technologies and Digital Health, both with the goal of developing biomedical technologies through collaborative efforts that merge scientific and technological capabilities with clinical need. Prior to her current position, Dr. Lash worked within the NIH’s science policy administration. During that time, she worked at the National Institute of General Medical Sciences and National Heart Lung and Blood Institute, as well as the NIH Office of the Director. Dr. Lash has been selected as a science policy fellow for both the American Association for the Advancement of Science (AAAS) and the National Academy of Engineering. She also has a background in small business innovation and intellectual property. Dr. Lash earned her Ph.D. in Physical Chemistry from North Carolina State University via a collaboration between the Departments of Chemistry and Chemical and Biomolecular Engineering. Her interdisciplinary research interests include microfluidics, biopolymers with controlled molecular architecture, and biosensor technologies.

Wendy Nilsen, Ph.D. is the Acting Deputy Division Director in the Information and Intelligent Systems Division of the Computer and Information Science and Engineering Directorate at NSF. She is also the lead Program Director in the Smart Health program. Her work has focused on the intersection of computing and human functioning. Her interests span the areas of sensing, analytics, cyber-physical systems, information systems, machine learning, artificial intelligence, and robotics. She also serves as cochair of the Health Information Technology Research and Development working group of the Networking and Information Technology Research and Development Program and, serving on numerous federal technology initiatives. Prior to joining NSF, Wendy was at the National Institutes of Health.

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 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.

Kimberly Sciarretta, PhD is the Solving Sepsis Program Manager within the Division of Research Innovation and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS). Previously Dr. Sciarretta was a Project Officer within the BARDA CBRN Division, and prior to that, was a technical consultant to multiple US Government Agencies. Dr. Sciarretta was one of the inaugural members of DRIVe and is leading efforts towards improving patient outcomes for sepsis through strategic interagency activities and critical technology investments with external partners. Dr. Sciarretta received her PhD from the University of Chicago in Molecular Genetics and Cell Biology. Her expertise broadly spans medical countermeasure development, biochemistry, synthetic biology, advanced manufacturing and chemical and biological defense technologies.

Dr. Andrew Weitz joined the NIBIB as a Program Director in 2017. He leads digital health strategy for the Rapid Acceleration of Diagnostics (RADx) initiative. Dr. Weitz also provides programmatic oversight to Stimulating Peripheral Activity to Relieve Conditions (SPARC), a program focused on electrical stimulation of peripheral nerves for treating various diseases and conditions.

Hui-Hsing Wong is a captain in the Commissioned Corps of the U.S. Public Health Service and a medical advisor to the Division of Research, Innovation, and Ventures (DRIVe) at BARDA. She has spent almost 15 years of her HHS career working on medical product development and safety, first as a primary reviewer at FDA; then in policy development at the Office of the Secretary where she oversaw the initial development of an active surveillance program for drug safety; reviewed FDA policies, guidance, and regulations at the Office of the Secretary; served as a strategic advisor for KidneyX; and led research projects on the econometric and regulatory aspects of medical product development, particularly incentives for development. Dr. Wong received a BS from Yale University, a JD from Columbia School of Law, an MD from Baylor College of Medicine. She trained in pediatrics at the Johns Hopkins Hospital. She is a member of the New York State Bar, licensed to practice medicine in Maryland, and is board-certified in pediatrics. She is a part-time staff pediatrician at the Walter Reed National Military Medical Center and an assistant professor of pediatrics at the Uniformed Services University of the Health Sciences in Bethesda, MD.