Health Regulators as Data Stewards

33 Pages Posted: 23 Aug 2014

See all articles by Kristin M. Madison

Kristin M. Madison

Northeastern University - School of Law; Northeastern University - Bouvé College of Health Sciences

Date Written: 2014


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.

Keywords: health information, big data, health informatics

Suggested Citation

Madison, Kristin M., Health Regulators as Data Stewards (2014). North Carolina Law Review, Vol. 92, pp. 1605-1636, 2014, Northeastern University School of Law Research Paper No. 195-2014, Available at SSRN:

Kristin M. Madison (Contact Author)

Northeastern University - School of Law; Northeastern University - Bouvé College of Health Sciences ( email )

416 Huntington Avenue
Boston, MA 02115
United States

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