There is perhaps no area of law that so effectively protects human health and thereby advances the right to the highest attainable standard of health, as tobacco control. Globally, tobacco is responsible for 1 in 10 adult deaths, and is on track to kill 10 million people per year, mostly in developing countries, representing a US$200 billion drain on the global economy. Yet experience in recent decades has shown that a range of tobacco control measures, such as comprehensive bans on smoking in public places, tobacco taxes, and limits on tobacco advertising, can greatly reduce smoking prevalence. These measures have slowly curtailed the epidemic, despite strong opposition from various sectors led by the tobacco industry. It is fitting that tobacco control is the focus of a recent, widely ratified global treaty (the Framework Convention on Tobacco Control) and of increasing national litigation, often directly linked to countries’ human rights commitments.

What does unethical behavior look like in everyday professional practice, and how might it become the accepted norm? Examinations of unethical behavior often focus on failures of individual morality or on psychological blind spots, yet unethical behaviors are generated and performed through social interactions across professional practices rather than by individual actors alone. This shifts the focus of behavioral ethics research beyond the laboratory exploring motivation and cognition and into the organizations and professions where unethical behavior is motivated, justified, enabled and supported in specific social contexts. For instance, when pharmaceutical firms fund academic research, how do the funding arrangements intersect with individual behaviors that are typical in academic research? In turn, how do academic-industry interactions affect scientific norms, particularly those involving compliance with rules, regulations, and ethical codes of conduct? A social organization approach to ethics allows us not only to examine ethics in practice, but also to tease apart unethical behaviors that might operate on an unreflective level and become accepted as “just the way it is.”

Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources (e.g., medicines, supplies, personnel). To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches on how best to allocate scarce resources to protect the public's health. Though beneficial in some jurisdictions, these approaches fail to clarify how the type and amount of care delivered in major emergencies might be curtailed. This is due, in part, to a lack of meaningful guidance on shifting standards of care in major emergencies.

According to the Social Security Administration, 98% of minor children are eligible to receive survivors benefits if a working parent dies. However, the eligibility of children born, and even conceived, after a working parent dies is less clear. In recent years, the Social Security Administration has received more than 100 applications for survivors benefits filed on behalf of children conceived after a parent's death, and one such case, Astrue v. Capato, was heard by the U.S. Supreme Court in 2012. In that case, whether the child is eligible to inherit under state intestacy law was accepted as a reasonable — and is a common — approach for determining eligibility for Social Security survivors benefits. The purpose of this study is to examine attitudes concerning access to Social Security survivors benefits (hereafter referred to as survivors benefits) in the context of various reproductive pathways and varying state intestacy laws.

Post-traumatic stress disorder (PTSD) is a “young” disorder formally recognized in the early 1980s, although the symptoms have been noted for centuries particularly in relation to military conflicts. PTSD may develop after a serious traumatic experience that induces feelings of intense fear, helplessness or horror. It is currently characterized by three key classes of symptoms which must cause clinically significant distress or impairment of functioning: (1) persistent and distressing re-experiencing of the trauma; (2) persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness; and (3) persistent symptoms of hyper-arousal. One of the possible symptoms within the second class is difficulty in remembering an important aspect of the traumatic event.

PTSD is not an uncommon condition, with an estimated lifetime prevalence of about 7-9% based on studies conducted in the United States and Canada, with women at higher risk than men. While not everyone who experiences a significant trauma will go on to develop PTSD, about a third will do so. Sexual assault, along with other forms of assaultive violence, pose a comparatively high risk of PTSD.

In 2010, in connection with the Patient Protection and Affordable Care Act (Obamacare), the United States Congress passed the Physician Payment Sunshine Act. This legislation requires pharmaceutical companies, medical device companies, and other manufacturers of medical supplies to collect information on their payments to physicians, beginning on August 1, 2013, and to annually report this information to the Centers for Medicare and Medicaid Services (CMS), beginning on March 31, 2014. All payments of over $10 are to be reported and aggregate payments of more than $100 to a single physician in a single year must also be reported.

On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.

It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions (FAQs), there have been no significant amendments to the Privacy Rule since 2003.

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production.

We argue for the existence of a state constitutional legal right to language. Our purpose here is to develop a legal framework for protecting the civil rights of the deaf child, with the ultimate goal of calling for legislation that requires all levels of government to fund programs for deaf children and their families to learn a fully accessible language: a sign language. While our discussion regards the United States, the argument we make is based on human rights and the nature of law itself, and can likely be adapted to any country.

We begin with an introduction to the biological facts surrounding language acquisition and how these facts impact the deaf child, where lack of language has devastating effects on individuals and negative effects on society in general.

The accelerating adoption of electronic health record (EHR) systems will have profound impacts on clinical care. It will also have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs.

Much has been written about the risk of EHR privacy breaches. This paper focuses on a different set of concerns, those relating to data quality. Unlike clinical trial data, EHR data is not recorded primarily to meet the needs of researchers. Because of clinicians’ workloads, poor user-interface design, and other factors, EHR data is surprisingly likely to be erroneous, miscoded, fragmented, and incomplete. Although EHRs eliminate the problem of cryptic handwriting, other kinds of errors are more common with EHRs than with paper records.

Laws, ordinances, regulations, and executive orders create the powers and duties of public health agencies and modify the complex community conditions that affect health. Appropriately trained legal counsel serving as legal advisors on the health officer's team facilitate clear understanding of the legal basis for public health interventions and access to legal tools for carrying them out.

Legal counsel serve public health agencies via different organizational arrangements — e.g., internal staff counsel, external counsel from the state attorney general's (AG) office, state health department, county or city, or private counsel under contract, or in combination. As of 2011, most state health departments (63%) employ their own counsel, and 56% use AG counsel, while 17% contract with independent attorneys; most local health departments (66%) work with attorneys and legal staff assigned by local government, by the state health agency (23%), or contract with outside attorneys and legal staff (15%).

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how organized psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process.

Some form of assisted dying (voluntary euthanasia and/or assisted suicide) is lawful in the Netherlands, Belgium, Oregon, and Switzerland. In order for individual instances of assisted dying to be lawful in these jurisdictions, a valid request must precede the provision of assistance to die. Non-adherence to the criteria for valid requests for assisted dying may be a trigger for civil and/or criminal liability, as well as regulatory sanctions where the assistor is a medical professional.

In this article, we review the criteria and evidence in respect of requests for assisted dying in the Netherlands, Belgium, Oregon, and Switzerland. Our aim is to establish whether individuals who receive assisted dying do so on the basis of valid requests.

Patents and free trade make strange bedfellows. For most of their history, patents have been instruments deployed to resist trade with other countries, not to enhance it. Whether one looks at Venetian laws that punished citizens who practiced local crafts outside the city, the Mercantilist uses to which patents were put in Elizabethan England, or the cartels of the 19th and 20th centuries created on a foundation of interlocking patent rights, patents have had a distinctly protectionist function. It is thus ironic that it is intellectual property rights in general, and patents in particular, that have been held up in recent years as the poster child of much that is wrong with globalization and free trade. Nowhere is this more so than in debates concerning international human rights law and patents, in particular the position that patents violate an international right to health.

Major disasters and public health emergencies constantly test the nation's resolve to rally and recover from tragedy. Public health crises stemming from prolonged threats like the 2009/2010 H1N1 influenza pandemic require sustained preparedness and response over many months. Even shorter-duration events, like tornados, earthquakes, or hurricanes, leave lasting impacts for which full recovery may take years. Telling examples include the displacement of thousands of persons across the Gulf Coast states following Hurricane Katrina in 2005 and difficulties obtaining basic housing and services that persisted in the Northeast months after Hurricane Sandy in 2012. Whether the result of natural disasters, infectious disease outbreaks, bioterrorism, or other causes, these events can change the societal landscape in affected regions.

Despite the challenges of recovery across populations stemming from national or regional emergencies, Americans have consistently supported those directly affected.

The genetic testing and screening of children has been fraught with controversy since Robert Guthrie developed the bacterial inhibition assay to test for phenylketonuria and advocated for rapid uptake of universal newborn screening in the early 1960s. Today with fast and affordable mass screening of the whole genome on the horizon, the debate about when and in what scenarios children should undergo genetic testing and screening has gained renewed attention. United States (US) professional guidelines — both the American College of Medical Genetics (ACMG)/American Society of Human Genetics (ASHG) statement (1995) and the American Academy of Pediatrics (AAP) Statement on the genetic testing of children (2001) and the new AAP and ACMG joint policy statement (2013) and technical report (2013) — as well as the old UK guidelines by the Working Part of the Clinical Genetics Society (1994) and the new United Kingdom (UK) guidelines by the British Society of Human Genetics (BSHG) (2010) all give the same answer: genetic testing and screening should only be done if it is in the child’s best interest.

The United States’ pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements, to directly influence and constrain the pharmaceutical coverage programs of its trading partners. The pursuit of increasing levels of intellectual property (IP) protection in successive bilateral and regional trade agreements has been driven, at least in part, by a U.S. desire to achieve standards of protection it anticipated from the TRIPS Agreement, but failed to secure. Despite the conclusion of a global agreement on IP standards that would establish significant protections in countries that had hitherto declined them, the U.S. pharmaceutical industry viewed TRIPS as falling well short of its objectives — particularly in light of the delayed introduction of patent protection in countries that are key suppliers of generic medicines, such as India.

Human biological tissue samples are an invaluable resource for biomedical research designed to find causes of diseases and their treatments. Controversy has arisen, however, when research has been conducted with laboratory specimens either without the consent of the source of the specimen or when the research conducted with the specimen has expanded beyond the scope of the original consent agreement. Moreover, disputes have arisen regarding which party, the researcher or the source of the specimen, has control over who may use the specimens and for what purposes. The purposes of this article are: (1) to summarize the most important litigation regarding the use of laboratory specimens, and (2) to demonstrate how legal theory regarding control of laboratory specimens has evolved from arguments based upon property interests in biological samples to claims that the origins of laboratory specimens have privacy interests in their genetic information that should be protected.

The Food and Drug Administration (FDA) authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label.

In Canada (as elsewhere) there is a growing demand for human eggs for reproductive purposes and currently demand exceeds supply. This is not surprising, as egg production and retrieval is onerous. It requires considerable time, effort, and energy and carries with it significant physical and psychological risks. In very general terms, one cycle of egg production and retrieval involves an estimated total of 56 hours for interviews, counseling, and medical procedures (i.e., screening, hormonal stimulation, and egg retrieval). The screening carries risks of unanticipated findings with severe consequences for insurability (which can be catastrophic). The daily hormone injections can be painful and uncomfortable, causing cramping, abdominal pain, nausea, vomiting, bloating, mood changes, and irritability.