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Journal Article

Citation

Evans BJ. J. Law Med. Ethics 2020; 48(Suppl 1): 74-81.

Affiliation

Barbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law, a Professor of Electrical and Computer Engineering, and the Director of the Center for Biotechnology & Law at the University of Houston.

Copyright

(Copyright © 2020, American Society of Law, Medicine and Ethics, Publisher John Wiley and Sons)

DOI

10.1177/1073110520917031

PMID

32342738

Abstract

The individual right of access to one's own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA's right of access to one's own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals' ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA's investigational device exemption requirements.


Language: en

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