The science of genetics holds great promise. Ideally, the more scientists learn about the human genome and the functions of specific genes, the better they will understand what causes disease, what can prevent disease and what can cure it. But the hoped for advances in medicine that genetics may bring about will never happen if people are afraid to provide their DNA and work with scientists and doctors on the necessary research. From a privacy perspective, two things are clear: 1) people are afraid of genetic testing and 2) genetic information has been used to hurt people, rather than to help them.

The 21st Century Cures Act (“Cures Act”) relies on the concept of real-world evidence (“RWE”) to improve the Food and Drug Administration (“FDA”) approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also caution that claims about RWE's wide-ranging, ameliorative impact on the health care system are likely overstated.

The real world of RWE is messy and uncertain. Successfully incorporating RWE into regular health care system decision-making, beyond the FDA, faces considerable obstacles and limitations. We review the reasons to be wary about RWE as a game-changer. These concerns including data reliability, insufficient incentives for stakeholders to generate and engage with high-quality RWE, and lack of comprehensive regulatory oversight. In addition, the push for RWE may impact the enforcement of the health care fraud and abuse laws, perhaps not in necessarily positive ways. Increased reliance on RWE may have significant implications for off-label fraud enforcement, further conflating the distinction between claims that are false for reimbursement rather than for scientific purposes.

H.L.A. Hart has stated that certain mental conditions have an “excusing” effect on punishment, whereby “[t]he individual is not liable to punishment if at the time of his doing what would otherwise be a punishable act he is … the victim of certain types of mental disease.” The Supreme Court, however, upheld a state statute allowing for increased “punishment,” in the form of civil commitment, for sexually violent predators who suffer from a “mental abnormality.” Thus, American jurisprudence is faced with a paradoxical role of mental conditions: serving to both aggravate and mitigate sentences. This dual purpose of mental conditions becomes a pressing legal issue as mental conditions associated with brain structure or function become more detectable with the emergence of neuroimaging.

In federal capital sentencing, judges are obligated to consider aggravating and mitigating factors before imposing a death sentence. There are aggravating and mitigating factors that could be implicated by mental conditions, including future dangerousness, and impaired capacity, respectively.

Healthcare database analyses (claims, electronic health records) have been identified by various regulatory initiatives, including the 21st Century Cures Act and Prescription Drug User Fee Act (“PDUFA”), as useful supplements to randomized clinical trials to generate evidence on the effectiveness, harm, and value of medical products in routine care. Specific applications include accelerated drug approval pathways and secondary indications for approved medical products. Such real-world data (“RWD”) analyses reflect how medical products impact health outside a highly controlled research environment. A constant stream of data from the routine operation of modern healthcare systems that can be analyzed in rapid cycles enables incremental evidence development for regulatory decision-making.

Key evidentiary needs by regulators include 1) monitoring of medication performance in routine care, including the effectiveness, safety and value; 2) identifying new patient strata in which a drug may have added value or unacceptable harms; and 3) monitoring targeted utilization. Four broad requirements have been proposed to enable successful regulatory decision-making based on healthcare database analyses (collectively, “MVET”): Meaningful evidence that provides relevant and context-informed evidence sufficient for interpretation, drawing conclusions, and making decisions; valid evidence that meets scientific and technical quality standards to allow causal interpretations; expedited evidence that provides incremental evidence that is synchronized with the decision-making process; and transparent evidence that is audible, reproducible, robust, and ultimately trusted by decision-makers.

Evidence generation systems that satisfy MVET requirements to a high degree will contribute to effective regulatory decision-making. Rapid-cycle analytics of healthcare databases is maturing at a time when regulatory overhaul increasingly demands such evidence. Governance, regulations, and data quality are catching up as the utility of this resource is demonstrated in multiple contexts.

The relations between physicians and lawyers have deteriorated rapidly over the past several decades, most particularly since the early 70s when the perception that a medical malpractice crisis existed in America became widespread. Some believe that the factors dividing the two professions are linked (1) to professional jealousy, (2) to sometimes conflicting economic interests, or (3) to difficulties in communication, since both professions use many of the same words, or terms of art, but with different intended meanings.

While the authors agree that these factors may have aggravated the problem, they believe that the conflict’s real roots are in the very different ways in which physicians and lawyers are trained and in the different epistemologies that each profession has accepted, as a result of which each reasons and solves problems in a manner that not only diverges from but sometimes contradicts the other’s. The authors conclude that only as the varying epistemologies begin to converge can physicians and lawyers begin to approach problems in more similar ways, and to discover the underlying compatibility of many of their interests and goals.

Someday soon, virtually any pregnant woman will be able to learn — with 98-99% accuracy — whether her fetus has contracted a serious genetic disorder by undergoing nothing more than an inexpensive, non-invasive blood test. For years, scientists have sought a method of prenatal testing that could boast both high levels of accuracy and low levels of risk. The most promising solution lies in an exciting recent discovery: tiny quantities of fetal cells and DNA cross over into the mother's bloodstream during pregnancy. If the fetal genetic material can be successfully isolated from the maternal blood, it can be used to diagnose a number of genetic disorders, such as Down Syndrome, cystic fibrosis, Tay-Sachs disease, and sickle cell anemia. Indeed, researchers have spent the last decade developing ways to accomplish this.

While the new Health Insurance Privacy and Accountability Act (HIPAA) research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States. Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties.

Recent news stories, medical journal articles, and two state voter referenda have publicized physicians’ providing their patients with aid-in-dying. This Note distinguishes two components of aid-in-dying: physician-assisted suicide and physiciancommitted voluntary active euthanasia. The Note traces these components’ distinct historical and legal treatments and critically examines arguments for and against both types of action. This Note concludes that aid-in-dying measures should limit legalization initiatives to physician-assisted suicide and should not embrace physician-committed voluntary active euthanasia.

We are told that functional magnetic resonance imaging (fMRI) is “not ready for use, despite optimism about its commercial potential.” This is probably true—it is also, in terms of legal analysis, irrelevant. Although the development of fMRI technology is still in its relative infancy, there is no guarantee that the law governing its use will wait for it to grow up. Thus, the recent backlash against the initial flurry of articles, both academic and general, on the promise and legal issues surrounding fMRI is unwarranted. The conclusion that so many—even many of the contributors to this volume—seem to be drawing, namely, that law, as a field, must abstain from analyzing the legal implications of fMRI until those with more scientific expertise deem it ready to look at, is at best wrong and, at worst, irresponsible.

The author focuses this Article upon the aspect of the Saikewicz decision which determines that the kind of “proxy consent” question involved in that case requires for its decision “the process of detached but passionate investigation and decision that forms the ideal on which the judicial branch of government was created.” This aspect of the decision has drawn much criticism from the medical community on the ground that it embroils what doctors believe to be a medical question in the adversarial processes of the court system. The author criticizes the decision from an entirely opposite perspective, arguing that the court's opinion fails in not laying down guidelines that would assure a truly adversary process in Saikewicz-type cases. He agrees with the Saikewicz court that our democratic institutional structure and societal commitment to individual liberty require that persons not competent to consent for themselves to acts of euthanasia be protected by a process of “detached but passionate investigation and decision.” However, he points out that this ideal of the court system was not realized in Saikewicz itself and is not likely to be realized in other cases without reform of some of the procedures currently being employed by the courts in “proxy consent” cases. Drawing on previous articles that he has written in related areas, he then proposes a set of guidelines that he believes not only will remove existing procedural deficiencies, but also may reform some aspects of the existing system that have drawn criticism from the medical community.

Some sources condemn judicial decisions which authorize the withdrawal of artificial nutrition from permanently unconscious patients. These critics assert that withdrawal of nutrition from a preservable unconscious patient amounts to intentional killing of a helpless human being. Grave implications are seen for helpless patients.

This article confronts these critics and their assertions. The author contends that the judicial approach which allows withdrawal of artificial nutrition is fully consistent with traditional medico-legal doctrines. The article articulates a standard — respect for human dignity — which justifies withdrawal of artificial nutrition from a permanently unconscious patient. The implications of this formula for other imcompetent patients facing a protracted dying process is discussed. Finally, the article explains why active euthanasia can and ought to be distinguished from withdrawal of life-preserving medical intervention.

Much recent analysis of health care insurance reform emphasizes economic and policy issues. In contrast, this Article examines health policy issues from the viewpoint of medical ethics. The critical ethical “problem” in health care today is that ability to pay determines the availability and quality of care. This Article discusses three types of proposed solutions: health care insurance reform, health care financing reform, and health care cost reform. It sketches an ethical framework for evaluating health policy and presents seven specific propositions that an ethical analysis of health care reform proposals raises. This Article concludes that remedying the unethical treatment of certain classes of patients requires both health care financing reform and health care cost reform; health care insurance reform will not suffice.

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports “that meet [Food and Drug Administration] standards for being clinically and scientifically valid.” Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of “informed consent” began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy—but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach?

This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing.

DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as “intended for entertainment purposes only,” it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that “includes” reports that meet FDA qualifications, despite disclaimers of intent to “provide medical advice.” The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller.

This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

The medical community and policy-makers have widely accepted peer review of physicians as essential to encouraging high quality medical practice. Peer review is a process by which members of a hospital's medical staff review the qualifications, medical outcomes and professional conduct of other physician members and medical staff applicants to determine whether the reviewed physicians may practice in the hospital and, if so, to determine the parameters of their practice.

In 2007, an estimated 33.2 million people were living with HIV, 2.5 million had become infected, and 2.1 million died from the virus. The majority of infected individuals reside in Africa, where in some countries as many as 33.4% of adults have HIV. In developed countries, effective drug therapies have reduced AIDS-related deaths by over seventy percent each year. These drugs have been so effective that over the last two years the global number of individuals dying from AIDS-related illness has actually declined. These therapies, however, are currently sold for $10,000 USD a year, a purchase price that is not feasible for low income countries where the annual health expenditure may be only $29 per person. A lack of essential medicine is not only a problem for those suffering from AIDS. Low and middle-income countries are disproportionately burdened by many additional chronic and infectious illnesses. The World Health Organization (“WHO”) estimates that one third of the world's population cannot regularly access essential medicines. The WHO cites the high cost of drugs as one of the major hurdles countries face in obtaining access to medication. However, the high cost of these brand-name medications does not reflect their minimal production costs. Drug manufacturers can produce generic versions of these drugs for as little as 1/30th of the cost of their brand-name counterparts.

The Revolving Fund of the Pan American Health Organization (PAHO) has an almost 30 year track record of providing access to essential vaccines for the entire population of Latin America and the Caribbean region. The activities of the PAHO Revolving Fund, coupled with the provision of high-quality technical assistance, were crucial to the successful control, elimination, or eradication of most of the region's great childhood killers, including measles and polio. Today, however, the Revolving Fund faces new challenges in the form of procuring a new generation of vaccines for human papillomavirus infection, rotavirus, and pneumococcal disease, which are priced orders of magnitude higher than the traditional childhood vaccines. The high cost of these essential new vaccines may require the PAHO Revolving Fund to establish innovative financial mechanisms for procuring these products at prices affordable for national immunization programs in Latin America and the Caribbean. The alternative, namely to bypass the Revolving Fund, could severely threaten the health of the region, especially Latin America's poorest people.

Brain imaging is one of the most remarkable technological advances towards understanding the relationship of behavior to brain anatomy and physiology. Brain images provide insight to understanding behavior. Additionally, the images themselves carry great impact, particularly when used to show differences in either the anatomy or the biological functioning of two different brains. For these reasons, brain images have increasingly been used in both criminal and civil trials.

After describing some general features of brain imaging, we will focus on functional magnetic imaging (fMRI), as many believe this technology has the most potential for advancing our understanding of how parts of the brain function, including perhaps linking specific functions with cognition and behavior. Brain imaging as a field is vast and therefore our discussion will be limited. First, we will assess the advantages and limitations of fMRI, including research efforts towards standardizing equipment thereby assuring reliability and reproducibility.

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.