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1. Barbara J. Evans, Congress' New Infrastructure Model of Medical Privacy, 84 NOTRE DAME L. REV _ (2009) (Forthcoming). Available: http://ssrn.com/abstract= 1186462. This article addresses the regulatory challenges of die federal government's new patient Nationwide Health Information Network (NHIN orThe Sentinel System), a database to be administered by the Food and Drug Administration (FDA). The database will include patients' Medicare, military, and private insurance claims data, health records, pharmaceutical purchase data, and "other data as the Secretary [of Health and Human Services (HHS)] deems necessary." The project's goal is to improve access to information about drug safety and aims to include health information on 25 million patients by 2010, and 100 million patients by 2012. Drug safety information currently is provided primarily by clinical trials, which often miss rare risks, and risks of problematic drug interactions, off-label uses or long-term use of a drug. Characterizing the project as a national infrastructure development mandate, the author argues the FDA currently is not well-suited to its new duties which will include regulating how and by whom the health information data will be collected, used and maintained, and the applicability of the Health Insurance Portability and Accountability Act Privacy Rule, applicable to the NHIN by Congressional mandate.
2. Fred H. Cate, Government Data Mining: The Need For A Legal Framework, 43 Harv. C.R.-C.L. L. Rev. 435 (2008). This article discusses the massive increase in recent years of the federal government's collection of personal data on individuals. Although much of the information was previously available, recent technological and legal developments in the availability, collection and organization of information have significantly expanded the federal government's ability to compile detailed dossiers on individual persons.The article discusses 1) the broad range of data collection programs, 2) the current regulatory framework for die collection and use of the data, and 3) the impact of data collection on individuals.The author strongly criticizes the government's data collection programs' efficacy and protections for personal privacy, and recommends a baseline legal framework for regulating government data mining activities.
3. John H.Walsh, Institution-Based Financial Regulation: A Third Paradigm, 49 Harv. Int'l LJ. 381 (2008). The author argues that an" institution based" paradigm for financial regulation is an emerging alternative to the traditional principles based (regulated entities must...