May 6, 2016
Conferences
2015-2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

VIDEO: Welcome, I. Glenn Cohen, Holly Fernandez Lynch, Urs Gasser, and Effy Vayena
VIDEO: Panel 1, Barbara Evans, "Big Data and the Meaning of Individual Autonomy in a Crowd"
VIDEO: Panel 1, Jeffrey Skopek, "Privacy in Numbers? Biological Bodies of Data, Big Data's Epistemology, and the Legal and Ethical Status of Health Inferences"
VIDEO: Panel 1, Tal Zarsky, "Correlation v. Causation in Health-Related Big Data Analysis: The Role of Reason and Regulation"
VIDEO: Panel 1, Nicolas Terry, "Big Data, Regulatory Disruption, and Arbitrage in Health Care"
VIDEO: Panel 1, Audience Q & A moderated by Urs Gasser
VIDEO: Panel 2, Efthimios Parasidis, "The Future of Pharmacovigilance: Big Data as Fraud Enabler and Fraud Detector"
VIDEO: Panel 2, Sharona Hoffman, "Big Data and the Americans with Disabilities Act: Amending the Law to Cover Discrimination Based on Data-Driven Predictions of Future Illnesses"
VIDEO: Panel 2, Sarah Malanga, "Big Data Neglects Populations Most in Need of Medical and Public Health Research and Interventions"
VIDEO: Panel 2, Carmel Shachar, "Potential Roadblocks in Health Care Big Data Collection: Gobeille v. Liberty Mutual, ERISA, and All-Payer Claims Databases"
VIDEO: Panel 2, Audience Q & A moderated by I. Glenn Cohen
VIDEO: Panel 3, Dov Greenbaum, "Avoiding Regulation in the Medical Internet of Things"
VIDEO: Panel 3, Marcus Comiter, "Data Policy for Internet of Things Healthcare Devices: Aligning Patient, Industry, and Privacy Goals in the Age of Big Data"
VIDEO: Panel 3, Audience Q & A moderated by Nathan Cortez
VIDEO: Keynote Introduction, Effy Vayena
VIDEO: Keynote, Isaac Kohane, "A Data Perspective on Autonomy, Human Rights, and the End of Normality"
VIDEO: Keynote, Audience Q & A
VIDEO: Panel 4, Catherine M. Hammack, "Thought Leader Perspectives on Risks and Protections in Precision Medicine Research"
VIDEO: Panel 4, Brent Mittelstadt, "From Protecting Individuals to Groups in Biomedical Big Data"
VIDEO: Panel 4, Donna Gitter, "Informed Consent and Privacy of De-Identified and Estimated Data: Lessons from Iceland and the United States in an Era of Computational Genomics"
VIDEO: Panel 4, Audience Q & A moderated by Effy Vayena
VIDEO: Panel 5, Laura Odwazny, "Regulations Are Not the Barrier to Use of Big Data in Health Research: Tensions Between Privacy Lapses and 'Minimal Risk'"
VIDEO: Panel 5, Liza Dawson, "The Common Rule and Research with Data, Big and Small"
VIDEO: Panel 5, Margaret (Mimi) Foster Riley, "Big Data, HIPAA, and the Common Rule: Time for Big Change?"
VIDEO: Panel 5, Audience Q & A moderated by Holly Fernandez Lynch
VIDEO: Panel 6, W. Nicholson Price II, "Regulating Complex Algorithmic Medicine"
VIDEO: Panel 6, Jeffrey Senger, "Regulating Next Generation Clinical Decision Support: The Challenge of Ensuring Safety and Effectiveness at the Interface of Big Data and Human Medical Judgment"
VIDEO: Panel 6, Ameet Sarpatwari, "Data Sharing that Enables Post-Approval Drug and Device Research and Protects Patient Privacy: Best Practice Recommendations"
VIDEO: Panel 6, Audience Q & A moderated by Jerry Avorn
VIDEO: Panel 7, Timo Minssen, "Big Data and Intellectual Property Rights in the Health and Life Sciences"
VIDEO: Panel 7, Brenda M. Simon, "The Pathologies of Biomedical ‘Data-Generating’ Patents: Leveraging Intellectual Property and Big Data to Extend Market Power"
VIDEO: Panel 7, Audience Q & A moderated by Rachel E. Sachs

Couldn't join us in person? Check out the conversation on Twitter @PetrieFlom and #BigDataandHealthLaw!

Video of the full conference will be available on this website in a few weeks. To be notified when the video is posted, sign up for our newsletter!

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference focused on “Big Data, Health Law, and Bioethics.”  The conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records.

Underlying these and many other potential uses, however, are a series of legal and ethical challenges relating to, among other things, privacy, discrimination, intellectual property, tort, and informed consent, as well as research and clinical ethics.

This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S. We expect to publish the conference proceedings in an edited volume. Keep an eye on the Petrie-Flom website or sign up for our newsletter for updates!

Agenda

All panels included time for audience Q & A.

8:00 - 8:30am, Registration and Breakfast

8:30 - 8:35am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

  • Holly Fernandez Lynch, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School and Faculty, Center for Bioethics, Harvard Medical School

  • Urs Gasser, Professor of Practice, Harvard Law School and Executive Director, Berkman Center for Internet & Society at Harvard University

  • Effy Vayena, Division Head, Health Ethics and Policy Lab, Department of Public Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich

8:35 - 9:55am, Panel 1: Shifting Paradigms: Big Data’s Impact on Health Law and Bioethics

  • Barbara Evans, University of Houston Law Center - Big Data and the Meaning of Individual Autonomy in a Crowd

  • Jeffrey Skopek, University of Cambridge Faculty of Law - Privacy in Numbers? Biological Bodies of Data, Big Data's Epistemology, and the Legal and Ethical Status of Health Inferences

  • Tal Zarsky, University of Haifa Faculty of Law - Correlation v. Causation in Health-Related Big Data Analysis: The Role of Reason and Regulation

  • Nicolas Terry, Robert H. McKinney School of Law, Indiana University - Big Data, Regulatory Disruption, and Arbitrage in Health Care

  • Moderator: Urs Gasser, Harvard Law School and the Berkman Center for Internet & Society at Harvard University

9:55 - 10:05am, Break

10:05 - 11:25am, Panel 2: Overcoming the Downsides of Big Data

  • Efthimios Parasidis, Moritz College of Law, The Ohio State University - The Future of Pharmacovigilance: Big Data as Fraud Enabler and Fraud Detector

  • Sharona Hoffman, Case Western Reserve University School of Law - Big Data and the Americans with Disabilities Act: Amending the Law to Cover Discrimination Based on Data-Driven Predictions of Future Illnesses 

  • Sarah Malanga, James E. Rogers College of Law, University of Arizona (and Jonathan D. Loe and Christopher T. Robertson) - Big Data Neglects Populations Most in Need of Medical and Public Health Research and Interventions

  • Carmel Shachar, Health Law and Policy Clinic, Harvard Law School (and Aaron S. Kesselheim, Gregory Curfman, and Ameet Sarpatwari) - Potential Roadblocks in Health Care Big Data Collection: Gobeille v. Liberty Mutual, ERISA, and All-Payer Claims Databases

  • Moderator: I. Glenn Cohen, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

11:25am - 12:10pm, Panel 3: The Internet of Things and Health Big Data

  • Dov Greenbaum, Yale School of Medicine - Avoiding Regulation in the Medical Internet of Things

  • Marcus Comiter, Harvard University - Data Policy for Internet of Things Healthcare Devices: Aligning Patient, Industry, and Privacy Goals in the Age of Big Data 

  • Moderator: Nathan Cortez, SMU Dedman School of Law

12:10 - 12:30pm, Break to Pick Up Lunch

12:30 -1:20pm, Keynote: A Data Perspective on Autonomy, Human Rights, and the End of Normality

  • Isaac (Zak) Kohane, Chair, Department of Biomedical Informatics, Harvard Medical School

1:20 - 1:30pm, Break

1:30 - 2:30pm, Panel 4: Protecting Health Privacy in a World of Big Data

  • Catherine M. Hammack, Duke University School of Medicine (and Laura Beskow, Kevin McKenna, and Kathleen M. Brelsford) - Thought Leader Perspectives on Risks and Protections in Precision Medicine Research

  • Brent Mittelstadt, Oxford Internet Institute - From Protecting Individuals to Groups in Biomedical Big Data

  • Donna Gitter, Zichlin School of Business, Baruch College - Informed Consent and Privacy of De-Identified and Estimated Data: Lessons from Iceland and the United States in an Era of Computational Genomics

  • Moderator: Effy Vayena, Health Ethics and Policy Lab, Department of Public Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich

2:30 - 3:30pm, Panel 5: Oversight of Big Data Health Research: Proposals for Improvement 

  • Laura Odwazny, Public Health Division, Office of the General Counsel, U.S. Department of Health and Human Services - Regulations Are Not the Barrier to Use of Big Data in Health Research: Tensions Between Privacy Lapses and “Minimal Risk”

  • Liza Dawson, Research Ethics Team, Basic Sciences Program, Division of AIDS, NIAID/NIH/DHHS - The Common Rule and Research with Data, Big and Small

  • Margaret (Mimi) Foster Riley, University of Virginia School of Law (and Robert J. Meyer) - Big Data, HIPAA, and the Common Rule: Time for Big Change?

  • Moderator: Holly Fernandez Lynch, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School and the Center for Bioethics, Harvard Medical School

3:30 - 3:40pm, Break

3:40 - 4:40pm, Panel 6: Big Data and the FDA

  • W. Nicholson Price II, University of New Hampshire School of Law - Regulating Complex Algorithmic Medicine

  • Jeffrey Senger, Sidley Austin LLP (and Patrick O’Leary) - Regulating Next Generation Clinical Decision Support: The Challenge of Ensuring Safety and Effectiveness at the Interface of Big Data and Human Medical Judgment

  • Ameet Sarpatwari, Harvard Medical School and Brigham and Women's Hospital (and Bradley A. Malin, Aaron S. Kesselheim, Joshua J. Gagne, and Sebastian Schneeweiss) - Data Sharing that Enables Post-Approval Drug and Device Research and Protects Patient Privacy: Best Practice Recommendations

  • Moderator: Jerry Avorn, Harvard Medical School and Brigham and Women's Hospital

4:40 - 5:25pm, Panel 7: Calibrating Intellectual Property Rights for Health Big Data

  • Timo Minssen, Centre for Information & Innovation Law, University of Copenhagen - Big Data and Intellectual Property Rights in the Health and Life Sciences

  • Brenda M. Simon, Thomas Jefferson School of Law (and Ted Sichelman) - The Pathologies of Biomedical ‘Data-Generating’ Patents: Leveraging Intellectual Property and Big Data to Extend Market Power

  • Moderator: Rachel E. Sachs, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

5:25 - 5:30pm, Closing remarks

Learn More

Slide Presentations

 

Bioethics Forum

Several of our presenters blogged about their research at the Hastings Center's Bioethics Forum. Check out their posts!

Check out past Petrie-Flom conferences, including full video of many events, in our Events Archive!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund. This year’s conference is organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich. 

     

Videos

VIDEO: Welcome, I. Glenn Cohen, Holly Fernandez Lynch, Urs Gasser, and Effy Vayena
VIDEO: Panel 1, Barbara Evans, "Big Data and the Meaning of Individual Autonomy in a Crowd"
VIDEO: Panel 1, Jeffrey Skopek, "Privacy in Numbers? Biological Bodies of Data, Big Data's Epistemology, and the Legal and Ethical Status of Health Inferences"
VIDEO: Panel 1, Tal Zarsky, "Correlation v. Causation in Health-Related Big Data Analysis: The Role of Reason and Regulation"
VIDEO: Panel 1, Nicolas Terry, "Big Data, Regulatory Disruption, and Arbitrage in Health Care"
VIDEO: Panel 1, Audience Q & A moderated by Urs Gasser
VIDEO: Panel 2, Efthimios Parasidis, "The Future of Pharmacovigilance: Big Data as Fraud Enabler and Fraud Detector"
VIDEO: Panel 2, Sharona Hoffman, "Big Data and the Americans with Disabilities Act: Amending the Law to Cover Discrimination Based on Data-Driven Predictions of Future Illnesses"
VIDEO: Panel 2, Sarah Malanga, "Big Data Neglects Populations Most in Need of Medical and Public Health Research and Interventions"
VIDEO: Panel 2, Carmel Shachar, "Potential Roadblocks in Health Care Big Data Collection: Gobeille v. Liberty Mutual, ERISA, and All-Payer Claims Databases"
VIDEO: Panel 2, Audience Q & A moderated by I. Glenn Cohen
VIDEO: Panel 3, Dov Greenbaum, "Avoiding Regulation in the Medical Internet of Things"
VIDEO: Panel 3, Marcus Comiter, "Data Policy for Internet of Things Healthcare Devices: Aligning Patient, Industry, and Privacy Goals in the Age of Big Data"
VIDEO: Panel 3, Audience Q & A moderated by Nathan Cortez
VIDEO: Keynote Introduction, Effy Vayena
VIDEO: Keynote, Isaac Kohane, "A Data Perspective on Autonomy, Human Rights, and the End of Normality"
VIDEO: Keynote, Audience Q & A
VIDEO: Panel 4, Catherine M. Hammack, "Thought Leader Perspectives on Risks and Protections in Precision Medicine Research"
VIDEO: Panel 4, Brent Mittelstadt, "From Protecting Individuals to Groups in Biomedical Big Data"
VIDEO: Panel 4, Donna Gitter, "Informed Consent and Privacy of De-Identified and Estimated Data: Lessons from Iceland and the United States in an Era of Computational Genomics"
VIDEO: Panel 4, Audience Q & A moderated by Effy Vayena
VIDEO: Panel 5, Laura Odwazny, "Regulations Are Not the Barrier to Use of Big Data in Health Research: Tensions Between Privacy Lapses and 'Minimal Risk'"
VIDEO: Panel 5, Liza Dawson, "The Common Rule and Research with Data, Big and Small"
VIDEO: Panel 5, Margaret (Mimi) Foster Riley, "Big Data, HIPAA, and the Common Rule: Time for Big Change?"
VIDEO: Panel 5, Audience Q & A moderated by Holly Fernandez Lynch
VIDEO: Panel 6, W. Nicholson Price II, "Regulating Complex Algorithmic Medicine"
VIDEO: Panel 6, Jeffrey Senger, "Regulating Next Generation Clinical Decision Support: The Challenge of Ensuring Safety and Effectiveness at the Interface of Big Data and Human Medical Judgment"
VIDEO: Panel 6, Ameet Sarpatwari, "Data Sharing that Enables Post-Approval Drug and Device Research and Protects Patient Privacy: Best Practice Recommendations"
VIDEO: Panel 6, Audience Q & A moderated by Jerry Avorn
VIDEO: Panel 7, Timo Minssen, "Big Data and Intellectual Property Rights in the Health and Life Sciences"
VIDEO: Panel 7, Brenda M. Simon, "The Pathologies of Biomedical ‘Data-Generating’ Patents: Leveraging Intellectual Property and Big Data to Extend Market Power"
VIDEO: Panel 7, Audience Q & A moderated by Rachel E. Sachs

Tags

bioethics   biotechnology   genetics   health information technology   health law policy   human subjects research   privacy   regulation   research