Law can greatly facilitate responses to public health emergencies, including naturally-occurring infectious disease outbreaks and intentional or accidental exposures to chemical, biological, radiological, or nuclear (CBRN) agents. At the federal level, the Secretary of the Department of Health and Human Services (HHS), as the lead for federal public health and medical responses to public health emergencies and incidents, has a range of authorities to support federal, state, tribal, local, and territorial responses. For example, under the Public Health Service (PHS) Act, the Secretary may provide temporary assistance to States to meet health emergency needs or deploy medicine and supplies from the Strategic National Stockpile. The Secretary also may determine that a disease or disorder presents a public health emergency, which may be the first step in triggering other critical legal authorities for response.

Since the 2001 anthrax attacks, one focus of public health preparedness has been on developing, distributing, and rapidly dispensing medical countermeasures (MCMs) for CBRN emergencies and pandemics.

Despite shifts in rhetoric and some positive movement, Americans with the disease of addiction are still often stigmatized, criminalized, and denied access to evidencebased care. Dramatically reducing the number of lives unnecessarily lost to overdose requires an evidence-based, equity-focused, well-funded, and coordinated response. We present in this brief article evidence-based and promising practices for improving and refocusing the response to this simmering public health crisis. Topics covered include improving clinical decision-making, improving access to non-judgmental evidence-based treatment, investing in comprehensive public health approaches to problematic drug use, and changing the way law enforcement actors interact with people who use drugs.

Many believe that nanotechnology will be disruptive to our society. Presumably, this means that some people and even whole industries will be undermined by technological developments that nanoscience makes possible. This, in turn, implies that we should anticipate potential workforce disruptions, mitigate in advance social problems likely to arise, and work to fairly distribute the future benefits of nanotechnology. This general, somewhat vague sense of disruption, is very difficult to specify – what will it entail? And how can we responsibly anticipate and mitigate any problems? We can't even clearly state what the problems are anticipated to be. In fact, when we move from sweeping policy statements to more concrete accounts, nanotechnology seems to bifurcate into two divergent streams: one is fairly continuous with current developments, extending extant science in a quantitative way; the other is radically new, and includes science fiction-like dreams of molecular manufacturing and assemblers, with their utopian (or dystopian) scenarios of absolute plenty (or runaway self-replication). In these cases, “disruption” takes on the valence of Huxley's brave new world.

Antibiotic research and development (R&D) has failed to produce innovative antibiotics in the past two decades, which is due to both scientific and economic factors. We reviewed national and international funding agencies and critically assessed current grant funding mechanisms. Finally, we propose four complementary grant-funding incentives aimed to help developers along the R&D pipeline. Equally important objective of these incentives is to address some of the known R&D risks and bottlenecks.

A single defining question perennially intrigues scholars and practitioners interested in public heath: To what extent should human rights be limited to protect the community’s health and safety? The question achieved prominence in the aftermath of the attacks on the World Trade Center and Pentagon on September 11, 2001 and with the intentional dispersal of anthrax spores through the U.S. Postal Systein. The conflict between security and public health intensified with the development of the Model State Emergency Health Powers Act (“Model Act”), drafted by the Center for Law and the Public’s Health at the request of the Centers for Disease Control and Prevention. The Model Act grants states consiclernble powers to control persons and property in response to a public health emergency, defined to inclucle bioterrorism or the appearance of novel or previously controlled or eradicated infectious agents or biological toxins.

It is one of the remarkable and significant consequence of the AIDS epidemic that out of the context of enormous suffering and death there emerged a forceful set of ideas linking the domains of health and human rights. At first, the effort centered on the observation that protecting individuals from discrimination and unwarranted intrusions on liberty were, contrary to previous epidemics, crucial to protecting the public health and interrupting the spread of HIV But in fairly short order, the scope of the health and human rights perspective expanded dramatically to focus on the ways in which the most fundamental social arrangements rendered individuals and communities vulnerable to HIV Racial and ethnic minorities, those who were marginalized, and women were at risk because of their subordinate status. In the face of such an understanding, nothing short of social change could be adequate to the challenge posed by the AIDS epidemic.

Medicalized Death and the Right to Die Movement Prior to the 20th Century, most Americans died at home, surrounded by family, friends, and neighbors. Religion, not medicine, governed the death bed for there was little physicians could do for the dying. Eventually, however, advances in medicine and technology would lead to dramatic changes in the timing and location of death: patients not only began living longer, they were also dying longer, and unlike their predecessors, were more likely to die alone, in institutions, and among strangers. Modern medicine, in its zeal to conquer death, had become obsessed with its curative function and ability to extend the lives of the dying. To many in the medical community, death represented failure and was something to be avoided at all costs, and like many other social problems in the United States, had become medicalized.

How should we oversee new and emerging technologies and their products? What lessons can we discern from existing regulatory examples and from past mistakes? How do these lessons learned translate into informed recommendations for adequate oversight for nanotechnology to avoid repeating the mistakes of the past? The investigators of this interdisciplinary project undertook this endeavor intending to answer these questions among others.

In parallel with the project team putting together this symposium, another, very different process on the oversight of nanotechnology took place. An international coalition of non-governmental organizations (NGOs) formed to address the nanotech policy dialogue. The first goal of this NGO group was to agree upon and draft fundamental principles of oversight, which it completed in 2007-08. These principles close with a call for their adoption and/or internalization by all relevant actors and bodies. In effect, they serve a function in the policy dialogue similar to that of this project’s forthcoming recommendations.

In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health (NIH), U.S. Centers for Disease Control and Prevention (CDC), and the Bill and Melinda Gates Foundation (Gates Foundation) testing the safety and efficacy of tenofovir (Viread), an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials.

The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent process. Too often, the sharing of information has been replaced by the mere acquisition of agreement with the authority ostensibly offering a choice.

Scholars of informed consent agree that its salience and its legitimacy derive from a fiduciary duty to inform, in order to respect, protect, and promote autonomous decision making by those to whom the duty is owed.

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.

Epidemiology is the study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control of health problems.

Several terms used in this definition require discussion. “Study” encompasses (a) observations in public health practice, e.g. to investigate outbreaks of food poisoning, identify the source of an epidemic, trace contacts of sexually transmitted diseases; (b) hypothesis-testing observational studies using cross-sectional, cohort and casecontrol methods; and (c) experiments such as randomized controlled trials, in which there is intervention as well as observation, usually with the aim of evaluating a preventive, diagnostic or therapeutic regimen or procedure. “Distribution” refers to time sequences, places of occurrence, and persons affected. “Determinants” are all the physical, biological and behavioral factors that can influence health. “Health-related states or events” include diseases, injuries, deaths, behaviors such as tobacco addiction, and reactions to preventive, diagnostic or therapeutic regimens or procedures.

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

The potential power of predictive genetic testing as a risk regulator is impressive. By identifying asymptomatic individuals who are at risk of becoming ill, predictive genetic testing may enable those individuals to take prophylactic measures. As new therapies become available, the usefulness of genetic testing undoubtedly will increase. Further, when a person's family medical history indicates a propensity towards a particular genetic disease, a negative test result may open up otherwise denied opportunities by showing that this person has not inherited suspect genes. In the latter type of case, a negative test result may reassure the individual that pursuing a particular course of action (such as planning a family or training for a job) is worthwhile, or may convince prospective employers that the individual will be a serviceable employee.

Health care reform that includes universal coverage could lower a major barrier to care for people of color and ethnic minorities—the inability to pay for care. But universal coverage alone, even with comparable fee-for-service payment or appropriately risk-adjusted capitated reimbursement, will not eradicate the racial and ethnic inequities in health care delivery. Restrictive admissions practices, geographic inaccessibility, culture, racial stereotypes, and the failure to employ minority health care professionals will still create barriers to minority health care. In addition to universal financing, health care reform should include new civil rights legislation to address and reduce these noneconomic barriers to minority health care.

Public disclosure of industry payments to physicians is one way to address financial conflicts of interest in medicine. As part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act (PPSA) requires pharmaceutical, medical device, and biologics manufacturers who have at least one product reimbursed by Medicare or Medicaid to disclose payments to physicians and teaching hospitals on a public website starting in 2014. The physician payment data will contain individual physician names, monetary values, and specific products connected to payments.

According to the Final Regulations issued by the Centers for Medicare and Medicaid Services (CMS) in February 2013, the law will make transparent the extent and nature of relationships between physicians, teaching hospitals, and manufacturers.

A major issue facing the health of both minors and young adults in the United States is the often unintentional lack of confidentiality maintained in the provision of sensitive health services. Studies have shown that access to confidential care is crucial for minors seeking preventive care and treatment for sensitive services. Evidence demonstrates that many minors will not seek health care if confidentiality cannot be ensured, which can have significant negative health implications; this finding can be extended to young adults covered under their parents health plans. Young adults, not just minors, also often forgo important sensitive services when they face a breach of confidentiality, which most likely occurs when their parents have access to the adult child's health information.

Currently, private insurance companies generally send the policyholder an explanation of benefits (EOB) whenever a service is provided under a plan. EOBs generally include information identifying the patient, provider, type of care received, total charge for services, amount paid by the insurance company, and any financial obligation of the policyholder.