Profoundly more data-intensive than conventional medicine, precision medicine’s distinctive informational needs present new challenges for healthcare management. Data protection and privacy law are key determinants in precision medicine’s future. This article examines legal and regulatory barriers to the incorporation of precision medicine into healthcare. Specific attention is paid to analyzing recent health privacy laws, court cases, and medical device regulations. Considering the challenges identified, recommendations and guidance are crafted for health leaders with reference to domestic and international initiatives.
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