The Research Exemption Carve Out: Understanding Research Participants Rights Under GDPR and U.S. Data Privacy Laws

15 Pages Posted: 1 Apr 2020 Last revised: 10 Apr 2020

See all articles by Mabel Crescioni

Mabel Crescioni

University of Arizona - Mel and Enid Zuckerman College of Public Health

Tara Sklar

University of Arizona - James E. Rogers College of Law

Date Written: April 10, 2020

Abstract

The use of medical and wellness devices containing sensor technology continues to evolve as does the protection of an individual’s data privacy for consumers as well as research participants. While the European Union has taken affirmative steps to address data privacy and use through the passage of the General Data Protection Regulation (GDPR), the United States has begun to see the emergence of multiple legislative efforts at the federal and state levels aiming to address concerns. These legislative efforts have led to public discussion on how to optimally regulate data privacy and usage, with notable exemptions around research and innovation. This Article highlights recently passed state laws and the impact of the increasingly unclear regulatory landscape on data privacy in clinical trials, particularly with the growing use of real-world evidence. The need for regulatory harmonization within the United States and abroad sharpens as the costs to comply with varying state laws rises and may limit advancing the research enterprise without necessarily improving protections for the public’s privacy.

Keywords: GDPR, medical devices, wellness, data privacy, clinical trials, regulation, research

Suggested Citation

Crescioni, Mabel and Sklar, Tara, The Research Exemption Carve Out: Understanding Research Participants Rights Under GDPR and U.S. Data Privacy Laws (April 10, 2020). 60 JURIMETRICS J. 125 (2020); Arizona Legal Studies Discussion Paper No. 20-11. Available at SSRN: https://ssrn.com/abstract=3564698

Mabel Crescioni

University of Arizona - Mel and Enid Zuckerman College of Public Health ( email )

Tucson, AZ

Tara Sklar (Contact Author)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

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