Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers.

In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

There was an argument that the Obama Administration's lawyers could have made—but didn't—in defending Obamacare's individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals' healthcare savings and consumption decisions. Because consumer-directed healthcare, which reaches its apex when individuals self-insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the healthcare market that arise from individual decisions to self-insure. This argument would done a better job than the Obama Administration's of aligning the individual mandate with existing Commerce Clause and Necessary and Proper Clause precedent, and it would have done a better job of addressing the conservative Justices' primary concerns with upholding the mandate. This Article lays out this forgone defense of the individual mandate.

In 2008, an amendment was proposed to the Colorado Constitution that sought to attach the rights and protections associated with legal “personhood” to any human being from the moment of fertilization. Although the initiative was defeated, it sparked a nation-wide Personhood Movement that has spurred similar efforts at the federal level and in over a dozen states. Personhood advocates choose terms like “fertilization,” or phrases such as “human being at any stage of development,” to identify the “person”-defining moment in the reproductive process, and these designations have profound implications for reproductive choice. Proponents are outspoken in their desire to outlaw abortion, but they are less transparent about their intent with respect to other aspects of reproductive choice, such as contraception and infertility treatments.

This paper describes the background of the Personhood Movement and its attempt to achieve legal protection of the preborn from the earliest moments of biological development. Following the late 2011 failure of the personhood measure in Mississippi, the language used within the Movement was dramatically changed in an attempt to address some of the concerns raised regarding implications for reproductive choice. Putting abortion to one side, this paper identifies why the personhood framework that is contemplated by the proposed changes does not eliminate the potential for restrictions on contraception and in vitro fertilization (IVF) that put the lives of these newly recognized persons at risk; nor should it if proponents intend to remain consistent with their position. The paper goes on to suggest what those restrictions might look like based on recent efforts being proposed at the state level and frameworks that have already been adopted in other countries.

The modern food environment is considered a primary driver of obesity and other nutrition-related chronic diseases. A significant contribution to this environment is the proliferation of claims on food packaging that provides a misleading picture of a product's healthfulness. The Food and Drug Administration (FDA) is the agency responsible for food labels but it lacks the regulatory authority and adequate resources to address the majority of questionable labeling practices. The FDA's current system of enforcement is thus essentially based on voluntary compliance and consumer- and manufacturer-initiated litigation has not successfully filled the regulatory gap. This manuscript reviews the current state of food labeling claims and the FDA's inadequate authority over misbranded food products. It analyzes competing views on regulatory compliance strategies and argues that a regulatory overhaul consistent with the best science and the First Amendment is necessary. With increased resources and authority, the FDA can meet current public health challenges and adequately ensure that labels are clear and consumers are properly informed and protected.

Many states have enacted medical malpractice reforms, recognizing that their tort systems result in protracted litigation, high costs, and a large number of uncompensated victims. One proposed reform, an “early offer” system, allows a medical provider to make a financial offer covering an injured patient’s economic damages, which, if the patient accepts, precludes litigation. However, if a patient rejects an offer, he will face a higher burden of proof at trial. The early offer system seeks both to assure claimants receive prompt compensation for their economic damages, and to save insurers and providers litigation expenses and unreasonable damage payments.

A bustling, non-profit hospital bills an elderly patient more than $2,000 for a magnetic resonance imaging (MRI) scan ordered by his physician. Despite the enormous profits the hospital will accrue during the year, its total revenue stream will be tax-exempt because it qualifies as a § 501(c)(3) organization under the Internal Revenue Code (IRC). A hospital’s ability to navigate the tax system without serious ramifications presents potential issues, particularly as the healthcare market is undergoing gradual changes in the wake of the Affordable Care Act (ACA). An organization’s ability to obtain preferential § 501(c)(3) tax status by showing that it is “organized and operated exclusively” for one of the exempt purposes under the statute is a root cause of many problems. This involves fulfilling a two-prong test under IRC § 501(c)(3), which includes both an organizational and an operational component. Both tests have to be satisfied or the organization in question loses its tax-exempt status under § 501(c)(3).