Authority of the Food and Drug Administration to require data access and control use rights in the Sentinel data...

The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the U.S. Food and Drug Administration (FDA) to develop a 100-million-person health data network known as the Sentinel system. When fully operational, the Sentinel network will offer a very rich, very large health data resource that has the potential to become one of history's most powerful engines of biomedical innovation and clinical translation of discoveries. Who controls this asset will be a matter of great scientific and commercial importance. This article explores two key questions--data access and use rights--that are under debate as various parties jostle for control of the network: First, does FDA have legal authority to require private healthcare data environments--such as insurers, healthcare providers, pharmacists and other entities that hold data in administrative and clinical databases--to make data available for inclusion in the network? Second, who will decide how the network is used, once it is built? The article explains why a neutral analysis of these questions is essential as FDA designs the governance framework for protecting the diverse stakeholders who will be touched by the Sentinel network. The conclusion describes threats to network operations, including federal and state constitutional claims and state legislative interventions, which could arise if FDA fails to devote timely attention to these issues.