The American health care system long has been distinctive in its embrace of market forces. For-profit private insurers play a major role in providing coverage, though they operate alongside public insurance programs that cover over one-third of the population. Historically, federal and state governments’ regulation of insurance markets was limited, leaving insurers to set premiums and coverage rules largely as they saw fit.

Government’s role in controlling health care spending has been even more circumscribed. Purchasing power is fragmented, with each insurer negotiating its own rates with physicians and hospitals. A formidable medical-industrial complex of for-profit providers, from hospitals to home-health care agencies, dialysis facilities, pharmaceutical companies and much more, has arisen to sell services.

Over the past decade, a flurry of media stories devoted to sports-related concussions have drawn attention to the previously “silent epidemic” of traumatic brain injury (TBI) in athletes. From 2001 to 2009, the annual number of sports-related TBI emergency department visits in individuals age 19 and under climbed from 153,375 to 248,414, an increase of increase of 62 percent. Multiple head injuries place youth athletes at risk for serious health conditions, including cerebral swelling, brain herniation, and even death — postconcussive conditions that have collectively (and controversially) been referred to as “second impact syndrome.” Studies have shown that children and teens — and girls, in particular — are more likely to sustain a concussion and have a longer recovery time than adults. Recent research also suggests that even subconcussive hits in children and adolescents may result in longer-term health effects such as decreased cognitive functioning, increased rates of depression, memory problems, and mild cognitive impairment (a pre-Alzheimer’s condition).

Sickle cell anemia (SCD) is a disease characterized by abnormal hemoglobin (Hb) structure. There is a mutation in the beta-globin gene that changes the sixth amino acid from glutamic acid to valine causing the mutated hemoglobin (HbS) to polymerize reversibly when deoxygenated to form a gelatinous network of fibrous polymers that stiffen and distort the red blood cell (RBC) membrane. This leads to episodes of microvascular vasoocclusion and premature RBC destruction leading to hemolytic anemia. For reasons that are unclear, some children develop a large artery vasculopathy (gradual narrowing and ultimate occlusion causing deprivation of blood to the brain — a stroke in other words) involving the intracranial arteries supplying the brain.

The risk of stroke for a child with SCD is many times greater than that of a healthy child without SCD or heart disease. There is a technique that allows the identification of the children with SCD who have high risk even within this relatively high-risk group. And there is a highly effective preventive treatment.

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?

Whole-genome sequencing (WGS) is proceeding apace. Academic centers have been performing whole-genome and -exome sequencing (WES) in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS.

Sickle cell disease (SCD) is an autosomal recessive hemoglobinopathy found mainly in populations of African and Mediterranean descent, including approximately 100,000 Americans. It is also very common in Spanish-speaking regions of Central America, South America, and parts of the Caribbean, in Saudi Arabia, and in India and Sri Lanka. The disorder is characterized most commonly by lifelong recurrent unpredictable vaso-occlusive pain that may be disabling, and by chronic tissue damage and organ dysfunction. There are several genotypes of the disease. Although SCD pain frequency generally varies between genotypes, it also varies between subjects even within genotype. It may worsen from childhood to adulthood. It may vary by gender. Its location, timing, and severity may be unpredictable.

Until recently, pain in SCD had been characterized as episodes that were acute, periodic, and relatively rare. Crises were viewed as usually associated with hospitalization. Many patients utilized hospital or emergency care for pain once per year or less, so painful episodes in SCD were called vaso-occlusive “crises.”

This text is about obtaining and sharing genetic information when there is a potential conflict of interests between patients and their families and relatives. The patient or, in this text, the “index-person,” is someone who is considering obtaining or already has obtained genetic information about herself through genetic testing.

The index-person can have several reasons to take an interest in obtaining her genetic information. She may want to know if she has a genetic predisposition for a disorder in order to take measures for preventing its development. Even if there are no preventive measures, as is the case with Huntington's disease, for instance, she may still want to know whether she has the mutation, in order to adjust her future plans. These interests that an individual may have in obtaining genetic information have been used to argue in favour of a right to know.

Hospice care in the United States has undergone a remarkable transformation since it assumed its modern form in the late 1960s. It began as a movement driven by small organizations staffed with many volunteer providers focusing on comprehensive spiritual, palliative, and mental health services for a relatively small number of terminally ill patients, typically suffering from cancer. The idea behind hospice during its early days was that a terminally patient and his or her family made a decision to focus on easing a patient’s pain and anxiety, making him or her more comfortable, rather than pursuing additional curative treatment. Because these objectives required a wide range of professional and non-professional skills, hospice care involved not only physicians and nurses, but clergy, social workers, volunteer caretakers, homemakers, and, of course, family members. The process of decision-making by the patient and his or her family was never uniform and never systematically studied.

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics (the “Myriad decision”) and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. This article explores the nature of these changes and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.

Oversight of genetic testing has, at least to date, had two major thrusts: (1) privacy and ethical protections and (2) traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy.

New coverage of the recent wars in Afghanistan and Iraq, and the ensuing public education campaigns by the Department of Veterans Affairs and private veterans advocacy groups combine to call the public's attention to the many potential mental health problems associated with traumatic event exposure. Indeed, since 2001, Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) combat and peacekeeping missions have been characterized by high levels of exposure to acts of extreme violence, with often gruesome effects. Less publically discussed is the fact that a surprisingly large number of United States civilians also report exposure to traumatic events, such as severe interpersonal violence, natural disasters, and serious automobile accidents. In fact, approximately 70% of randomly sampled respondents indicated that they have experienced an incident characterized by significant perceived life threat at some point during their lives.

Concussion is a form of traumatic brain injury that has been defined as a “trauma-induced alteration in mental status that may or may not involve loss of consciousness.” Terms such as getting a “ding” or getting your “bell rung” are sometimes used as colloquialisms for concussion, but inappropriately downplay the seriousness of the injury. It is estimated that between 1.6 and 3.8 million concussions occur annually in the United States as a result of participation in sports or recreational activities. To date, there are no objective, biological markers for concussion; rather, the current diagnosis of concussion is dependent upon symptom reporting by the athlete. In the acute phase, concussions can result in a broad spectrum of symptoms that can be transient or last for days, weeks, or even months. Symptom prolongation is generally referred to as post-concussion syndrome.

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights (1997), Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”

Two narratives have emerged to describe recent health care reforms in the United States of America (US) and the United Kingdom (UK). One narrative speaks of revolution, that the adoptions of the Affordable Care Act 2010 (ACA) in the US, and the Health and Social Care Act 2012 (HSCA) in the UK, have resulted in fundamental, large-scale philosophical, political and legal change in the jurisdictions’ respective health care systems. The other narrative evokes evolution, identifying each new legislative scheme as a natural development of existing governance structures. Policymakers in both the US and UK face the problem of a health care system which, as traditionally envisaged, cannot offer universal access to health care at a reasonable, or politically acceptable, price

Children in North America, some as young as eleven or twelve, routinely don helmets and pads and are trained to move at high-speed for the purpose of engaging in repeated full-body collisions with each other. The evidence suggests that the forces generated by such impacts are sufficient to cause traumatic brain injury (TBI) among children. Moreover, there is only limited evidence supporting the efficacy of interventions typically used to reduce the risks of such hazards. What kind of risk assessment enables such activities to be a relatively common feature of childhood in Canadian and American society?

In order to understand this state of affairs, we must examine the particular risk frame under which such hazards are commonly assumed. Risk assessments are embedded in the cultures in which they are situated and must be evaluated in their social contexts.

Law plays a critical role in all stages of a public health emergency, including planning, response, and recovery. Public health emergencies introduce health concerns at the population level through, for example, the emergence of a novel infectious disease. In the United States, at the federal, state, and local levels, laws provide an infrastructure for public health emergency preparedness and response efforts: they grant the government the ability to officially declare an emergency, authorize responders to act, and facilitate interjurisdictional coordination. Law is perhaps most visible during an emergency when the president or a state's governor issues a disaster declaration establishing the temporal and geographic parameters for the response and making financial and other resources available. This legal authority has increasingly been used during the last decade.

Financial relationships and business transactions between physicians and the health care industry are common. These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples. Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the potential to produce positive collaborations that improve patient care and public health, and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”

However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust.

There are a number of considerations, including ethical and clinical or diagnostic factors, in utilizing the diagnosis of posttraumatic stress disorder (PTSD) in criminal proceedings. The reliability and validity of the diagnosis may be questioned. Legal precedent may consider extant diagnostic criteria for PTSD and comorbid diagnoses. However, these diagnostic criteria are often in flux considering new research findings. For example, the introduction of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, includes some changes in the PTSD diagnostic criteria. How will this affect interpretation of past legal judgments? Moreover, PTSD has significant psychiatric comorbidity, e.g., substance abuse, which in itself may influence violent behavior and its consequences. Some of these comorbid diagnoses also have changes in their diagnostic criteria. The introduction of biological tests in the assessment of PTSD will likely facilitate more objective diagnosis.