for reading and for detailed comments. Thanks to the Fulbright-Schuman program, Institute for Information Law ("IViR") at the University of Amsterdam, and Scuola Sant'Anna in Pisa for the time and resources for this project. Thanks to the faculty of Tel Aviv University, the Second Annual Junior Faculty Forum on the Intersection of Law and Science, Technology, Engineering, and Math (STEM) at the Northwestern Pritzker School of Law, and my own Colorado Law School faculty for excellent workshop opportunities. Extra thanks to Matthew Cushing, whose incredible support made this project possible, and to Mira Cushing for joy beyond words.
Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space for regulatory arbitrage is changing. The long arms of Europe’s new General Data Protection Regulation (GDPR) and California’s new Consumer Privacy Act (CCPA) will reach shadow health records in many companies. In this article, we lay out the contours of the GDPR’s and CCPA’s impact on shadow health records and health data more broadly, highlight critical remaining uncertainty, and call for increased clarity from lawmakers and industry on the use of such data for research.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.