Health data regulation can be thought of at two levels. First, the micro- level of regulation has to do with Electronic Health Records (EHRs). Second, the macro-level concerns the networks on which EHRs are transmitted. The micro- and macro-levels of regulation interact. For example, EHRs need to be configured so that they can be transmitted on mandated networks. As a result, the lines do sometimes blur.

That said, the 21st Century Cures Act (Cures) clearly takes a dual approach to regulation. Cures was passed in December 2016 on a bipartisan basis. Its mandate was to address health data regulation at both the micro- and macro-levels. At the micro-level, Cures seeks to address the problem of information blocking. It seeks to configure EHRs such that their users are incentivized to share the information to the greatest degree possible. As I describe below, most penalties, however, apply only with respect to those who participate in the voluntary EHR certification program of the Office of the National Coordinator for Health Information Technology (ONC). At the macro-level, Cures seeks to promote the creation of a national health information network (NHIN). Like the certification program, participation in the network is voluntary.

To the extent much of Cures’ regulation relies on voluntary programs, regulatory arbitrage is easy. Firms can just choose not to participate in more robust regulation. However, in promulgating regulations, the Department of Health and Human Services (HHS) has taken steps to incent providers and other healthcare entities to participate both in the certification program and in the national network. I conclude that while the incentives for participation in the certification program will be effective, those for participating in the national network are less so. I make recommendations to make such participation highly desirable.

Part I offers a brief history of health data regulation. Part II offers an overview of Cures. Part III explains Cures information blocking rules, and the incentivized voluntary approach it has adopted there. Part IV explains steps ONC has taken with respect to creating a national network, and the shortcomings to the voluntary approach there. Part V offers a solution.

Craig Konnoth, Regulatory De-Arbitrage in Twenty-First Century Cures Act’s Health Information Regulation, 29 Annals of Health Law, 135–152 (2020).