The Sentinel Initiative as a Cultural Commons
In Governing Medical Research Commons, Cambridge University Press (Katherine Strandburg, et al. eds.) (2017)
23 Pages Posted: 17 Jun 2016 Last revised: 14 Oct 2017
Date Written: 2017
This case study applies the knowledge commons research framework to the U.S. Food and Drug Administration’s (FDA) Sentinel Initiative. That initiative resulted in the creation of the Sentinel System (Sentinel), a national electronic system to track the safety of medical products already on the market. Launched in 2008, it now includes information on over 178 million individuals — more than half the U.S. population. Sentinel was designed as a new tool for the agency, but it has the potential to fundamentally alter the way post-market surveillance is conducted.
This case study examines the aspects of Sentinel that are governed as commons, how those commons are governed, and who has access to the resources governed by commons. This includes the impact of limited government funding and political constraints on the structure and utilization of the initiative, FDA’s interactions with private and public healthcare data environments, and the agency’s framework for disseminating the data it has collected. The study finds that Sentinel’s structure and governance was largely dictated by Congress’ and the agency’s decision to rely on contracting and self-regulation rather than mandating data sharing. In turn, that necessitated a system design that could provide valuable regulatory information to the agency while still being palatable to insurance companies and health care providers. Likely as a result of a series of key strategic decisions, FDA was completely successful at meeting its Congressional mandate and developing new a functionality. However, these decisions may have sacrificed some utility.
This research promises an improved understanding of Sentinel that will be important for policy makers, and more broadly, for understanding how to effectively structure environments for developing and distributing scientific knowledge.
Keywords: Big data, food and drug regulation, public-private partnerships, distributive concerns, privacy
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