Biobank Research and Privacy Laws in the United States

23 Pages Posted: 2 May 2016 Last revised: 16 Sep 2016

See all articles by Heather L. Harrell

Heather L. Harrell

University of Louisville - Institute for Bioethics, Health Policy, and Law

Mark A. Rothstein

University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law

Date Written: April 20, 2016

Abstract

Privacy is protected in biobank-based research in the U.S. primarily by Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research and therefore neither applies to all biobank based research. Not only is it challenging to determine when the HIPAA Privacy rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. U.S. law also does not directly address international sharing of data or specimens outside of the EU - US Safe Harbor Agreement, which only applies to receipt of data by certain U.S. entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Keywords: biobanks, research ethics, privacy, common rule, HIPAA Privacy Rule, consent, HITECH Act, EU-US Safe Harbor, specimens, medical records

JEL Classification: K31, K32

Suggested Citation

Harrell, Heather L. and Rothstein, Mark A., Biobank Research and Privacy Laws in the United States (April 20, 2016). Journal of Law, Medicine and Ethics, Vol. 44, No. 1, 2016; University of Louisville School of Law Legal Studies Research Paper Series No. 2016-8. Available at SSRN: https://ssrn.com/abstract=2772700

Heather L. Harrell

University of Louisville - Institute for Bioethics, Health Policy, and Law

Louisville, KY 40202
United States

Mark A. Rothstein (Contact Author)

University of Louisville - Institute for Bioethics, Health Policy, and Law ( email )

Louisville, KY 40202
United States

HOME PAGE: http://www.louisville.edu/bioethics

University of Louisville - Louis D. Brandeis School of Law ( email )

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

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