Document Type



Rapidly improving abilities to assemble and analyze massive datasets have the potential to transform health, healthcare, and the healthcare system. This article argues that in an era of big data, government regulators have the power to shape this transformation. One step that the federal government has taken to accelerate the transformation process is to make data bigger. By acting as a data generator, collector, aggregator, facilitator, and funder, it has fostered the development and dissemination of information that is useful to many health system stakeholders. At the same time, the federal government has sought to make data smaller. Through initiatives such as quality reporting mandates and the Patient-Centered Outcomes Research Institute, it has sought to ensure that data is analyzed and distilled in ways that make it more understandable and actionable for patients. Much more remains to be done, however, to achieve the promise of a third possible approach to system transformation: re-making data so that it will provide a firmer foundation for governmental functions. After reviewing how the federal government makes data bigger and smaller, this article argues that as data stewards, healthcare regulators should ensure that they develop and manage data so as to better inform their own regulatory decisions. It then explores how they might do so.

Date of Authorship for this Version



health information, big data, health informatics

Original Citation

Kristin M. Madison, Health Regulators as Data Stewards, 92 N.C. L. Rev., 1605 (2014).

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