Blumenthal explores how research data can have characteristics of a public good while simultaneously holding significant value and inherent costs as a private database asset. In addition, he discussed how taxpayer-funded data, collected and stored in a variety of public and private institutions, provide another opportunity to consider such data a public good. With taxpayer-funded data there is an obligation to evaluate the incentives of data aggregation along with the benefits of making such data more available. Ultimately this may lead to opportunities to have the public, legal, and legislative arenas address the future utility of clinical data.
The potential to support evidence-based medicine through the wide variety of prescription drug and medical databases continues to grow because these data can offer greater insight into the practices of care delivery and safety surveillance. Current data sources have been constructed to serve as potential resources for research and commercial endeavors. William Crown, president of i3 Innovus, offers ideas on the elements to consider in building large, multifaceted data assets. From a private-sector perspective, Crown outlines some of the potential standardization, privacy, and statistical challenges associated with data aggregation and provides insight into the variety of sources of clinical data. As guidance for future database developments, he characterizes the increasing demand for a data resource that draws information from multiple, diverse sources of medical data and, in turn, synthesizes those data into a tool available for a wide range of healthcare activities, including research and evidence generation.
Given the growing complexity of data gathering, access, and pooling, many legal issues must be considered. Nicolas Terry, Chester A. Myers Professor of Law and codirector of the Center for Health Law Studies at Saint Louis University School of Law, provides an overview of legal rules and regulations that preclude effective data sharing and aggregation. Terry elaborates on concepts of property and inalienability rules, the disconnect between federal and state regulations, and the continued development of legal models protecting privacy of health data. One area discussed is the notion of a combined National Committee on Vital and Health Statistics (NCVHS) secondary stewardship model with that of the European data directives, which might guard against data misuse while addressing the growing need for access to patient clinical information by supporting strong obligations for data stewards.