The “Internet of Things” and Clinical Research: Privacy, Security, and Ethical Aspects

Eric Meslin, PhD, Director of the Indiana University Center for Bioethics, Dean for Bioethics, Indiana University School of Medicine

Eric M. Meslin is founding Director of the Indiana University Center for Bioethics. He is also Associate Dean for Bioethics in the Indiana University School of Medicine, and is Professor of Medicine; of Medical & Molecular Genetics; of Bioethics and Law; and of Philosophy. His other leadership positions include directing the Indiana University-Moi University Academic Research Ethics Partnership, an NIH-funded bioethics training program in Eldoret, Kenya; the Bioethics and Subject Advocacy Program of the Indiana Clinical and Translational Science Institute; and co-directs the Indiana University Center for Law, Ethics and Applied Research in Health Information (CLEAR).
Born in Canada, Dr. Meslin received his B.A. from York University (Toronto), and his M.A. and Ph.D. from Georgetown University. He was director of bioethics research for the ELSI program at the National Human Genome Research Institute (1996-98), and Executive Director of the U.S. National Bioethics Advisory Commission (1998-2001) appointed by President Bill Clinton.

Dr. Meslin has more than 150 published articles and book chapters on various topics in bioethics and science and is a co-editor of the Cambridge University Press Bioethics and Law Series. He has been a member of several boards and including the Institute of Medicine’s Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs; the Ethics Subcommittee to the Director of the U.S. Centers for Disease Control and Prevention; and the Board of Directors of Genome Canada.

On May 9, 2007 he was appointed a Chevalier de L’Order Nationale du Mérite (Knight of the National Order of Merit) by the French Ambassador to the United States for contributions to French bioethics policy.

Jennifer Covich Bordenick, Co-Chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup, CEO of eHealth Initiative

For over 20 years, Jennifer has focused on quality and innovative technology solutions to transform healthcare. She is co-chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup; member of the Health Level Seven International (HL7) Advisory Council (providing framework and related standards for the exchange, integration, sharing, and retrieval of eHealth information); and member of the Diabetes Collaborative Stakeholder Panel.
Ms. Covich is CEO of eHealth Initiative which provides leadership for research, education and advocacy for innovative solutions to improve healthcare through information and technology. She works closely with executives from across the spectrum of healthcare, leading a coalition of 200 influential organizations. Her focus areas include improving health and wellness through innovative solutions; interoperability; accountable care; data exchange; privacy/security issues; and tech tools for chronic care.

Prior to joining eHI, Ms. Covich headed up the strategic marketing at OpenNetworks, Inc., focusing on security solutions for the healthcare industry. She led healthcare industry relations at MicroStrategy, Inc., focusing on data-mining solutions for the Pharmaceutical and healthcare industry. She spent four years at the National Committee for Quality Assurance as Director of Policy and Product Development, helping develop national quality standards for healthcare organizations. Jennifer began her career at the George Washington University Hospital, Medical Center and Health Plan working on quality management initiatives and healthcare administration. Ms. Covich earned a Master’s degree in Human Resource Development, completed coursework in health administration doctoral program at George Washington University in Washington DC.

Marvin Slepian, MD, Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., Founder and Director of The Arizona Center for Accelerated Biomedical Innovation

Marvin J. Slepian, M.D. is the Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., the owner and manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. He is the Founder and Director of ACABI – The Arizona Center for Accelerated Biomedical Innovation. He is a McGuire Scholar, Eller College of Management and a Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona.
Dr. Slepian has founded numerous medical device companies, including Focal (NASDAQ-traded, acquired by Genzyme), Endotex, Angiotrax and Hansen Medical, and has served as acting CEO and Board Member of several medical device startups. He is also Senior Strategic Adviser for Apurba Technologies Inc., a software development company that creates enterprise data solutions for data processing, visualization and analytics.

Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices, and is the holder of more than 25 issued and 41 filed patents. He is an expert in polymeric biomaterials and local drug delivery, and has also helped develop a new class of small, high-performance electronics that are biodegradable and capable of dissolving completely in water or bodily fluids. The applications most promising for this transient technology are medical implants, consumer electronics and environmental monitors.

He earned his A.B. in Biochemical Sciences and Science in Human Affairs from Princeton University, and his M.D. from the University of Cincinnati College of Medicine. Dr. Slepian completed his Internal Medicine training at NYU-Bellevue in New York where he was a Resident and Chief Resident in Medicine. He completed his Cardiology training at Johns Hopkins where he was a Clinical and Research Fellow. He completed a second fellowship in Interventional Cardiology at Cleveland Clinic. He has received additional post-doctoral training at MIT and Washington University.

Megan Doerr, MS, CGC, Principal Scientist, Governance Team, Sage Bionetworks

Megan Doerr, MS, CGC, is Principal Scientist with The Sage Bionetworks Governance team. Sage Bionetworks is a non-profit bioinformatics research organization focused on promoting innovative, open and collaborative science leveraging big data to improve human health. Sage’s Governance team generated the open-source Participant-Centered Consent (PCC) toolkit for e-consent recently utilized with Apple’s new ResearchKit and works with legal, ethical, and regulatory experts to develop and implement the policies and procedures for appropriate data access and sharing on Sage’s collaborative data platforms – including managing data captured from studies conducted through mobile technology platforms.
Prior to joining Sage Bionetworks, Ms. Doerr served as clinical lead for the development and use of Cleveland Clinic’s electronic family health history gathering tool. She received her undergraduate degree from the University of Vermont and her graduate degree in genetic counseling from Case Western Reserve University.

Ellen Kelso, Executive Director Strategic Development, Chesapeake IRB

Ellen Kelso has more than thirty-five years of experience in the Pharmaceutical industry and currently serves Chesapeake IRB as Executive Director Strategic Development. Prior to Chesapeake IRB, Ms. Kelso founded Goodwyn IRB and served for 15 years as Managing Member and Chief Executive Officer.
Ms. Kelso began her career with Eli Lilly and served the Pharmaceutical industry in clinical operations and both domestic and international regulatory affairs. Her experience includes leading project teams through development, production and approval of New Drug Applications (NDAs), managing worldwide regulatory strategies, establishing electronic publication, and document management and regulatory compliance processes. She has also successfully combined the expertise of academic and industry professionals to create best practices and leverage technology to enhance ethical review and human subject protections.

She serves on the Steering Committee of the public-private Clinical Trials Transformation Initiative to identify and promote practices that will increase the quality and efficiency of clinical trials, and the Drug Information Association Program Planning Committee. Ms. Kelso holds a BS degree in Microbiology and Molecular Biology from Indiana University and also has completed numerous professional and management training and development programs.