Biobank Research and Privacy Laws in the United States
23 Pages Posted: 2 May 2016 Last revised: 16 Sep 2016
Date Written: April 20, 2016
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: Suggested Citation