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Big Data, Health Law, and Bioethics

Big Data, Health Law, and Bioethics

c.$165.00 ( )

Effy Vayena, Urs Gasser, I. Glenn Cohen, Holly Fernandez Lynch, Barbara J. Evans, Jeffrey M. Skopek,Tal Z. Zarsky, Nicolas P. Terry, Efthimios Parasidis, Sharona Hoffman,Sarah E. Malanga, Jonathan D. Loe, Christopher T. Robertson, Kenneth S. Ramos, Carmel Shachar, Aaron S. Kesselheim, Gregory Curfman, Ameet Sarpatwari, Nathan Cortez, Dov Greenbaum, Marcus Comiter, Effy Vayena, Laura M. Beskow, Catherine M. Hammack, Kathleen M. Brelsford, Kevin C. McKenna, Brent Mittelstadt, Donna M. Gitter, Laura Odwazny, Liza Dawson, Margaret Foster Riley,Jerry Avorn,Bradley A. Malin, Joshua J. Gagne, Sebastian Schneeweiss, Jeffrey M. Senger, Patrick O'Leary, W. Nicholson Price II, Rachel E. Sachs, Timo Minssen, Justin Pierce, Ted Sichelman, Brenda M. Simon and Frank Pasquale.
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  • Publication planned for: March 2018
  • availability: Not yet published - available from March 2018
  • format: Hardback
  • isbn: 9781107193659

c.$ 165.00 ( )
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  • When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

    • Focuses deeply on a particular type of big data - that which is health related - but covering a wide variety of issues, including privacy, research, regulation, and more, as well as philosophical and practical considerations
    • The book is timely, with a unique focus and coverage
    • In addition to thoughtful academic discussions, chapters contain proposed solutions to existing challenges, which take a variety of approaches, from market-based to regulatory
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    Product details

    • Publication planned for: March 2018
    • format: Hardback
    • isbn: 9781107193659
    • dimensions: 228 x 152 mm
    • contains: 6 b/w illus. 2 tables
    • availability: Not yet published - available from March 2018
  • Table of Contents

    Introduction Effy Vayena, Urs Gasser, I. Glenn Cohen and Holly Fernandez Lynch
    Part I. Shifting Paradigms: Big Data's Impact on Health Law and Bioethics: Introduction Urs Gasser
    1. Big data and individual autonomy in a crowd Barbara J. Evans
    2. Big data's epistemology and its implications for precision medicine and privacy Jeffrey M. Skopek
    3. Correlation vs. causation in health-related big data analysis: the role of reason and regulation Tal Z. Zarsky
    4. Big data and regulatory arbitrage in healthcare Nicolas P. Terry
    Part II. Overcoming the Downsides of Big Data: Introduction I. Glenn Cohen
    5. The future of pharmacovigilance: big data and the False Claims Act Efthimios Parasidis
    6. Big data's new discrimination threats: amending the Americans with Disabilities Act to cover discrimination based on data-driven predictions of future disease Sharona Hoffman
    7. Who's left out of big data? How big data collection, analysis, and use neglects populations most in need of medical and public health research and interventions Sarah E. Malanga, Jonathan D. Loe, Christopher T. Robertson and Kenneth S. Ramos
    8. Potential roadblocks in health care big data collection: Gobeille v. Liberty Mutual, ERISA, and all-payer claims databases Carmel Shachar, Aaron S. Kesselheim, Gregory Curfman and Ameet Sarpatwari
    Part III. The Internet of Things (IoT) and Health Big Data: Introduction Nathan Cortez
    9. Avoiding over-regulation in the medical internet of Things Dov Greenbaum
    10. Data policy for internet of things health care devices: aligning patient, industry, and privacy goals in the age of big data Marcus Comiter
    Part IV. Protecting Health Privacy in the World of Big Data: Introduction Effy Vayena
    11. Thought leader perspectives on risks in precision medicine research Laura M. Beskow, Catherine M. Hammack, Kathleen M. Brelsford and Kevin C. McKenna
    12. From individual to group privacy in biomedical big data Brent Mittelstadt
    13. Big data and informed consent: the case of estimated data Donna M. Gitter
    Part V. Oversight of Big Data Health Research: Proposals for Improvement: Introduction Holly Fernandez Lynch
    14. Is there a duty to share health care data? I. Glenn Cohen
    15. Societal lapses in protecting individual privacy, the common rule, and big data health research Laura Odwazny
    16. The common rule and research with data, big and small Liza Dawson
    17. Big data, HIPAA and the common rule: time for big change? Margaret Foster Riley
    Part VI. Big Data, FDA, and Liability Considerations: Introduction Jerry Avorn
    18. Data sharing that enables post-approval drug and device research and protects patient privacy: best practice recommendations Ameet Sarpatwari, Bradley A. Malin, Aaron S. Kesselheim, Joshua J. Gagne, Sebastian Schneeweiss
    19. Big data and human medical judgment: regulating next generation clinical decision support Jeffrey M. Senger and Patrick O'Leary
    20. Medical malpractice and black-box medicine W. Nicholson Price II
    Part VII. Calibrating Intellectual Property Rights for Health Big Data: Introduction Rachel E. Sachs
    21. Big data and intellectual property rights in the health and life sciences Timo Minssen and Justin Pierce
    22. The pathologies of data-generating patents Ted Sichelman and Brenda M. Simon
    Epilogue: professional cooperation and rivalry in the future of data-driven healthcare Frank Pasquale.

  • Editors

    I. Glenn Cohen, Harvard Law School, Massachusetts
    I. Glenn Cohen is one of the world's leading experts on the intersection of bioethics and the law, as well as health law. He also teaches civil procedure. He is the author of more than 80 articles in venues like the New England Journal of Medicine, JAMA, Nature, and the Harvard Law Review, and the author, editor, or co-editor of eight books. He has appeared on or been covered by PBS, NPR, ABC, CNN, MSNBC, Jones, the New York Times, the New Republic, the Boston Globe, among other media venues. He has been a Radcliffe Institute and Hastings Center Fellow.

    Holly Fernandez Lynch, Harvard Law School, Massachusetts
    Holly Fernandez Lynch is an expert on issues at the intersection of law, bioethics, and health policy, in particular the regulation of research with human subjects and conflicts of conscience in health care. She published Conflicts of Conscience in Health Care: An Institutional Compromise (2008), and has released several co-edited volumes. In 2014, she was appointed as a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), US Department of Health and Human Services. She previously practiced FDA law, served as a bioethicist working with NIH's Division of AIDS, and staffed President Obama's Commission for the Study of Bioethical Issues.

    Effy Vayena, Harvard Medical School
    Effy Vayena, Ph.D., is an international expert on issues of ethics and policy in new health technologies. Her work has appeared in highly ranked journals such as the Lancet, PLoS Medicine and Proceedings of National Academies of Science. She has worked extensively in policy areas consulting for the World Health Organization and the Organization of Economic Co-operation and Development amongst others. She was elected member of the Swiss Academy of Medical Sciences and she chairs the Ethical, Legal and Societal Issues Advisory group of the newly established Swiss Personalised Health Network, a large scale, federally funded national program.

    Urs Gasser, Berkman Center for Internet and Society, Harvard University
    Urs Gasser is the Executive Director of the Berkman Klein Center for Internet and Society at Harvard University and a Professor of Practice at Harvard Law School. He serves on the boards of the NEXA Center for Internet & Society at the University of Torino, the Research Center for Information Law at the University of St Gallen, and the International Advisory Board of the Alexander von Humboldt Institute for Internet and Society in Berlin. He is a Fellow at the Gruter Institute for Law and Behavioral Research. Dr Gasser has written and edited several books, and published over 100 journal articles.

    Contributors

    Effy Vayena, Urs Gasser, I. Glenn Cohen, Holly Fernandez Lynch, Barbara J. Evans, Jeffrey M. Skopek,Tal Z. Zarsky, Nicolas P. Terry, Efthimios Parasidis, Sharona Hoffman,Sarah E. Malanga, Jonathan D. Loe, Christopher T. Robertson, Kenneth S. Ramos, Carmel Shachar, Aaron S. Kesselheim, Gregory Curfman, Ameet Sarpatwari, Nathan Cortez, Dov Greenbaum, Marcus Comiter, Effy Vayena, Laura M. Beskow, Catherine M. Hammack, Kathleen M. Brelsford, Kevin C. McKenna, Brent Mittelstadt, Donna M. Gitter, Laura Odwazny, Liza Dawson, Margaret Foster Riley,Jerry Avorn,Bradley A. Malin, Joshua J. Gagne, Sebastian Schneeweiss, Jeffrey M. Senger, Patrick O'Leary, W. Nicholson Price II, Rachel E. Sachs, Timo Minssen, Justin Pierce, Ted Sichelman, Brenda M. Simon and Frank Pasquale.

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