2016 Annual Conference: Big Data, Health Law, and Bioethics 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!

The vast prospects of Big Data and the shift to more “personalized”, “open” and “transparent” innovation models highlight the importance of an effective governance, regulation and stimulation of high-quality data-uses in the health and life sciences. Intellectual Property Rights (IPRs) and related rights come into play when research is translated into safe and efficient “real world” uses. While the need of recalibrating IPRs to fully support Big Data advances is being intensely debated among multiple stakeholders, there seems to be much confusion about the availability of IPRs and their legal effects. In this very brief presentation I intend to provide a very brief overview on the most relevant IPRs for data-based life science research. Realizing that the choice of how to address, use and interact with IPRs differs among various areas of applications, I also intend to sketch out and discuss selected areas that demonstrate emerging tensions and potential solutions at the interface of Big Data, Standardization and Intellectual Property Rights in the Health and Life Sciences.