Session II:
Approaches to Protecting Privacy & Confidentiality
Speakers representing diverse stakeholders in the research enterprise will discuss policies, techniques, and technologies for controlled use, data protection, and informed consent as ways to protect individual privacy and data confidentiality. The goal of this session is to explore the challenges of privacy protection for health-related big data research conducted on a variety of platforms and in various settings. Panelists will also consider the ethical and practical challenges posed by data-sharing across cultures and boundaries.
Moderator: Mark Barnes, J.D., LL.M.
Ropes & Gray, LLP
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Deborah Kilpatrick, Ph.D.
Evidation Health
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How one private company tackles privacy and confidentiality concerns with data collection, storage, and controlled access for research use of data generated through mobile technologies.
Andrew Shatto
Centers for Medicare & Medicaid Services
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A speaker from the Centers for Medicare & Medicaid Services will discuss their policies and practices on sharing data with diverse stakeholders to support meaningful research while protecting privacy.
Rebecca Li, Ph.D.
Vivli
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The challenges encountered and solutions implemented for protecting privacy and confidentiality of clinical research data on a shared platform that operates across geographical boundaries at Vivli, an independent global data-sharing and analytics platform for clinical research data.
Simson L. Garfinkel, Ph.D.
US Census Bureau
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The use of statistical methods including "differential privacy" to protect data.
- Go back to 2019 OHRP Exploratory Workshop
- Go to Session I: Is Privacy a Casualty of Advancing Research?
- Go to Session III: Protecting Privacy & Confidentiality: A Shared Responsibility
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Mark Barnes, J.D., LL.M. (Moderator)
Ropes & Gray, LLP
Since 2014, Mark has taught health care law and public health law at Yale University Law School, and since 1999, he has taught the history of the regulation of the medical profession and other legal-medical issues in the first year curriculum of Yale University Medical School. Mark is a partner at the international law firm, Ropes & Gray, where his client work focuses on human and animal research, stem cell and genetic research, research fraud, and international research. Mark formerly served at Harvard as the Senior Associate Provost for Research, and in 2004 started and directed for several years Harvard’s HIV/AIDS treatment programs in Nigeria, Tanzania, and Botswana. He has served as chief administrative officer at St. Jude Children’s Research Hospital, and has held senior appointed positions in the New York City and State departments of health. Mark is co-chair of the Subcommittee on Harmonization of Research Regulations, HHS Secretary’s Advisory Committee on Human Subjects Protections, and is a member of the Ethics Working Group of the NIH HIV Prevention Clinical Trials Network. He serves as the faculty Co-Chair of the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital, which works with researchers, industry and regulators to improve standards and regulations for clinical trials, with a focus on the emerging economies.
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Deborah Kilpatrick, Ph.D.
Evidation Health
Deborah Kilpatrick, Ph.D. is the CEO of the digital health company Evidation Health in California. Evidation is a new kind of health and measurement company that provides the world’s most innovative healthcare companies technology and expertise to understand how everyday behavior and health interact. Earlier in her career, she held multiple leadership roles in R&D, new technology development, and New Ventures at Guidant Corporation prior to its acquisition by Boston Scientific (NYSE: BSX), followed by commercial roles at genomic medicine company CardioDx. She currently sits on the college of engineering advisory boards for the Georgia Institute of Technology and the California Polytechnic State University. Deborah is a Director for Sleep Number (NASDAQ: SNBR), a fellow of the American Institute of Medical and Biological Engineering, and the co-founder of the MedtechVision Conference now held annually in Silicon Valley. She has has been named to FierceMedicalDevice’s Top Women in Medtech, FierceBiotech’s Top Women in Biotech, and Silicon Valley Business Journal’s 100 Women of Influence. She holds B.S., M.S. and Ph.D. degrees in engineering from Georgia Tech University.
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Andrew Shatto
Centers for Medicare and Medicaid Services (CMS)
Andrew Shatto is the Deputy Director of the Office of Enterprise Data and Analytics (OEDA) at CMS. Andy’s office manages the Chronic Conditions Data Warehouse (CCW) which includes the Research Data Distribution Center (RDDC) and the CMS Virtual Research Data Center (VRDC), the Qualified Entity (QE) Program, the CMS Privacy Board as well as the CMS Data Use Agreement process, and the Research Data Assistance Center (ResDAC). In addition, OEDA develops and maintains a variety of data products designed to provide CMS data to researchers in a linked, secure, and “cleaned up” way allowing analysis on Medicare and Medicaid beneficiaries to be completed across a broad continuum of care. Mr. Shatto has been working at CMS in various programming and data analysis capacities since 1997.
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Rebecca Li, Ph.D.
Vivli
Rebecca Li, Ph.D., is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard University Medical School. Previous to her current role, she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over five years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with expertise in Biotech, Pharma and CRO environments. She completed a fellowship in 2013 in the Division of Medical Ethics at Harvard University Medical School. She earned her Ph.D. in Chemical and Biomolecular Engineering from Johns Hopkins University.
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Simson L. Garfinkel, Ph.D.
US Census Bureau
Simson Garfinkel is the Senior Computer Scientist for Confidentiality and Data Access at the US Census Bureau. He holds seven US patents and has published more than 50 research articles in computer security and digital forensics. He is a fellow of the Association for Computing Machinery (ACM) and the Institute of Electrical and Electronics Engineers (IEEE), and a member of the National Association of Science Writers. His most recent book is The Computer Book, which features 250 chronologically arranged milestones in the history of computing. As a journalist, he has written about science, technology, and technology policy in the popular press since 1983, and has won several national journalism awards.
Garfinkel received three Bachelor of Science degrees from Massachusetts Institute of Technology (MIT) in 1987, a Master’s of Science in Journalism from Columbia University in 1988, and a Ph.D. in Computer Science from MIT in 2005.