Structural Challenges of Precision Medicine

9 Pages Posted: 14 Apr 2017

See all articles by Mark A. Rothstein

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 11, 2017


Precision medicine has three defining characteristics: (1) patient centered; (2) information intensive; and (3) resource dependent. Each of these elements present significant policy challenges for the successful integration of precision medicine into broad clinical practice. First, patient centered refers to precision medicine's greater emphasis on patient-derived data, such as from wearable devices and patient health apps, as well as greater patient involvement in their own health matters, such as through the use of patient portals and access to more granular health information. Second, information intensive refers to precisions medicine's embrace of big data concepts, besides genomics, to include geo-location information, consumer data, government records, and numerous other sources. The obvious concern is for the privacy of this information in light of the weakness of U.S privacy laws, such as the HIPAA Privacy Rule. Third, resource dependent highlights the higher costs associated with pharmacogenomics and other new products and services, as well as the likely limited access to more expensive technologies by vulnerable patients. In many ways, precision medicine highlights the structural problems of the U.S. health care system.

Keywords: Big Data, Genomics, Health Privacy, HIPAA Privacy Rule, Personalized Medicine, Pharmacogenomics, Physician-Patient, Precision Medicine, Precision Medicine Initiative

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A., Structural Challenges of Precision Medicine (April 11, 2017). Journal of Law, Medicine and Ethics, Vol. 45, No. 2, Forthcoming. Available at SSRN:

Mark A. Rothstein (Contact Author)

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

Louisville, KY 40202
United States


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

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

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