The Ethics and Laws of Medical Big Data

Cambridge Handbook of Information Technology, Life Sciences and Human Rights, Marcello Ienca, O. Pollicino, L. Liguori, R. Andorno & E. Stefanini (eds.) (Forthcoming)

Posted: 4 Mar 2021

See all articles by Hrefna D. Gunnarsdottir

Hrefna D. Gunnarsdottir

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL)

I. Glenn Cohen

Harvard Law School

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Sara Gerke

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Date Written: March 1, 2021

Abstract

The COVID-19 pandemic has highlighted that leveraging medical big data can help to better predict and control outbreaks from the outset. However, there are still challenges to overcome in the 21st century to efficiently use medical big data, promote innovation and public health activities and, at the same time, adequately protect individuals’ privacy. The metaphor that property is a “bundle of sticks”, each representing a different right, applies equally to medical big data. Understanding medical big data in this way raises a number of questions, including: Who has the right to make money off its buying and selling, or is it inalienable? When does medical big data become sufficiently stripped of identifiers that the rights of an individual concerning the data disappear? How have different regimes such as the General Data Protection Regulation in Europe and the Health Insurance Portability and Accountability Act in the US answered these questions differently? In this chapter, we will discuss three topics: (1) privacy and data sharing, (2) informed consent, and (3) ownership. We will identify and examine ethical and legal challenges and make suggestions on how to address them. In our discussion of each of the topics, we will also give examples related to the use of medical big data during the COVID-19 pandemic, though the issues we raise extend far beyond it.

Keywords: Big Data, Medicine, Ethics, Ownership, Informed Consent, Privacy, Data Sharing, COVID-19, EU Law, US Law

Suggested Citation

Gunnarsdottir, Hrefna D. and Cohen, I. Glenn and Minssen, Timo and Gerke, Sara, The Ethics and Laws of Medical Big Data (March 1, 2021). Cambridge Handbook of Information Technology, Life Sciences and Human Rights, Marcello Ienca, O. Pollicino, L. Liguori, R. Andorno & E. Stefanini (eds.) (Forthcoming), Available at SSRN: https://ssrn.com/abstract=3795470

Hrefna D. Gunnarsdottir

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL)

Karen Blixens Plads 16
Copenhagen S, 2300
Denmark

I. Glenn Cohen

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Sara Gerke (Contact Author)

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02138
United States

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