On behalf of the Robert Wood Johnson Foundation (RWJF), I want to thank the Public Health Law Association and the American Society of Law, Medicine & Ethics for your leadership and the work that both you and the Centers for Disease Control and Prevention (CDC) have done to grow this field. RWJF is pleased to co-sponsor this conference.

The music that opened this talk is a clip from Warren Zevon, who encouraged us musically to “send lawyers, guns and money.” Zevon was a singer/songwriter and social critic whose songs often took a jaundiced, somewhat cynical point of view. Even so, I know that I am probably stretching his meaning when I think of this song. I see “lawyers, guns and money” as his take on the major drivers of how change happens in a society.

No one who attended the 2010 national public health law conference hosted by the Public Health Law Association (PHLA) and the American Society of Law, Medicine & Ethics (ASLME) could miss the sense of excitement and momentum. The revival of this annual public health law meeting, with the support of the Robert Wood Johnson Foundation (RWJF), the energetic leadership of the PHLA president and board, ASLME’s expert guidance, and a rousing address by Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention (CDC), symbolize the continued commitment of a wide range of important individuals and institutions to the proposition that law is of substantial importance to public health. But there is more than just symbolism to be excited about. CDC’s public health law program continues to champion efforts to promote the use and understanding of law as a public health tool.

Does law matter regarding public health outcomes? Regardless of what one may think about the answer to this age-old question, in recent years the public health community has increasingly demonstrated and recognized the roles that public health laws and policies play in effectuating long-lasting and broad-based population-wide changes. Public health laws and policies have been instrumental in the following ways: reducing smoking prevalence; reducing underage alcohol-related drinking, driving, crashes, and fatalities; reducing exposure to second-hand smoke; eliminating vaccine–associated paralytic poliomyelitis (VAPP); increasing seat-belt use and reducing traffic fatalities; reducing dental carries; and reducing access to and consumption of unhealthy foods and beverages sold in schools and to reductions in caloric intake and overweight. In fact, in a review of the ten greatest public health achievements in the 20th century, all were influenced by policy change.

The concept of Health in All Policies aims to improve the health outcomes associated with policies in an attempt to mitigate health disparities and provide optimal environments for healthier living. This multidisciplinary framework seeks to improve health through effective assessment and reformation of policy for organizations of any level and stature. The importance of integrating health in policy assessment and decision making is a key concept in the growing field of Health Impact Assessment.

The World Health Organization defines Health Impact Assessment (HIA) as “a combination of procedures, methods, and tools by which a policy, program, or project may be judged as to its potential effects on the health of a population, and the distribution of those effects within the population.” HIA provides a mechanism for collaboration between various sectors and disciplines bridging the gap between research, policymaking, and implementation of policies, programs, and projects affecting health outcomes. In the United States, while some HIA efforts have focused on proposed public policies, HIA has been used primarily to analyze the health effects of proposed development projects and plans related to community design and transportation.

Current methods of obtaining an informed consent leave much to be desired. Patients rarely read consent forms or understand all of the risks, benefits, or alternatives associated with their treatment. Evaluating the advantages and disadvantages of treatment options often presents a more significant challenge for patients with lower levels of health literacy. This article reviews the evidence of shortcomings in our informed consent system and then explores the potential for a new approach to engage patients at all levels of health literacy in their treatment decisions. Specifically, the article will examine the potential of shared decision-making (SDM) to bridge gaps in knowledge, increase patient adherence to treatment, and improve health outcomes in low health literacy patient populations. Leveling barriers to treatment information for disadvantaged populations should be a public health imperative, especially if it can be shown to improve health outcomes and reduce health disparities.

Most people dread being the subject of interest for doctors, scientists, regulators, and lawyers. While we may joke about the arrogance of the medical profession and the aggressiveness of the legal field, both lie at the core of environmental public health (EPH). They are inseparable, sometimes complementary and other times in tension. The role of medicine and science in EPH is clear, but their relationship with law is often opaque. Yet in no other area of public health, from infectious and chronic disease prevention to providing health care in underserved communities, is law so central as an instrument and partner. In this article we explore the relationship of law and science in the broader context of EPH, beginning with an overview of potential goals and challenges. We then offer three organizing principles that inform and guide the integration of law, science and policy in EPH.

The governance structures of state public health systems vary as much as the states themselves, including the existence and role of state boards of health. Understanding these differences is essential to a complete understanding of the governmental public health enterprise. State boards of health are obvious vehicles for public health policy development in some states, where they work closely with or oversee state health agencies. In other states they do not exist or serve only in a non-binding advisory capacity.

In this article, we distinguish and identify state boards of health and state public health advisory boards, examine state boards of health in practice, and discuss their role in advocacy and policy development in the context of state politics. We used a set of mixed qualitative methods, including a literature review, online research of state statutes establishing state board of health authorities, and key informant interviews. Informants were five current and former state board of health members, four current and former state health officers, and nine state health agency senior policy staff, spanning 13 states.

Perhaps the most significant law affecting the provision of health services to the American Indian and Alaska Native (AI/AN) population is the Indian Self-Determination and Education Assistance Act of 1975 (ISDEAA, PL 93-638). This Act allows tribes to assume the management and control of health care programs from Indian Health Service (IHS) and to increase flexibility in health care program development. Under ISDEAA, tribes have the option to contract or compact with IHS to deliver health services using pre-existing IHS resources (formula-based shares tables determine funding for various IHS sites), third party reimbursements, grants, and other sources. Typically, tribes develop their own non-profit health care corporations to provide services to their community, and as a result are eligible for grants and other types of funding not available to federal agencies like IHS.

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A (H1N1) virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, from global to local.

Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization (WHO) reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher.

The detection and spread of pandemic 2009 H1N1 influenza in the United States led to a complex and multi-faceted response by the public health system that lasted more than a year. When the first domestic case of the virus was detected in California on April 15, 2009, and a second, unrelated case was identified more than 130 miles away in the same state on April 17, 2009, the unique combination of influenza virus genes in addition to its emergence and rapid spread at the end of the typical Northern Hemisphere influenza season suggested the potential for a high morbidity, high mortality event. In response, federal, state, and local public health officials conducted epidemiologic investigations with federal and state laboratory support to help to determine the scope of the H1N1 pandemic. On April 26, the Secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency that was renewed through June 23, 2010. The pandemic that ensued tested virtually every aspect of U.S. public health preparedness and response systems, from laboratory capabilities and capacities to social distancing plans.

The public safety, human services, health, and relief workers who comprise the first wave of a response to natural or man-made disasters play a critical role in emergency preparedness. These first responders provide care and services in the immediate aftermath of emergencies and may remain in affected communities for weeks or months. They often work long hours under stressful conditions, witnessing the human harms, physical destruction, and psychological devastation that can accompany disasters.

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome (SARS) outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) pursuant to the revised International Health Regulations [IHR (2005)], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services (HHS) made public health emergency and Public Readiness and Emergency Preparedness (PREP) Act declarations. In addition, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) (to allow the emergency use of certain antiviral medications, diagnostic tests, and respirators during the pandemic), and President Obama declared a National Emergency (to authorize the use of temporary waivers or modifications of certain federal requirements related to health care facility responses). Select state and local governments also declared emergencies.

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA or the Act) into law. ACA aims to improve access to care and health outcomes through a number of mechanisms, including requiring most individuals to carry health insurance, prohibiting insurers from denying health insurance coverage based on pre-existing conditions, and creating exchanges through which individuals and families not eligible for employer- or government-sponsored health insurance may purchase coverage. While the Act is aimed primarily at improving individual health by increasing access to health insurance, it also contains a number of provisions targeted directly at improving health at the population level. Most of these provisions, which encompass a variety of disease prevention and access-to-care initiatives, are found in ACA Title IV.

The Affordable Care Act1 (ACA) promises to improve access to coverage and care for two vulnerable groups: low-income persons who are excluded by a lack of resources and chronically ill and disabled people who are excluded by the dysfunction of our existing insurance and care delivery systems. ACA’s sprawling provisions raise a wealth of implementation challenges that are exacerbated by the compromises required to move reform through Congress. In particular, the compromise between regulatory/public program advocates and advocates for private, market-driven programs requires thoughtful regulatory coordination between public and private health systems.

The Patient Protection and Affordable Care Act (ACA) represents the most significant reform of the United States health care system in decades. ACA also substantially amplifies the federal role in health care regulation. Among other provisions, ACA expands government health care programs, imposes detailed federal standards for commercial health insurance policies, creates national requirements on employers and individuals, and enlists state administrative capacity to implement various federal reforms. In response, a persistent voice in the protracted, contentious debate surrounding ACA was, and continues to be, resistance from states. The rhetoric of federalism — states’ rights, reserved powers, state sovereignty, limited government, and local diversity — resonates deeply even around provisions of ACA that do not specifically implicate state interests. For example, the loudest and most persistent state objections target the new mandate that individuals maintain health insurance, a requirement imposed by ACA and enforced through federal tax penalties.

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 2014. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 2009 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44,000 per clinician under the Medicare incentive program and $63,750 per clinician under the Medicaid program.

Domestic litigation has become a principal strategy for realizing international treaty obligations for the human right to health, providing causes of action for the public’s health and empowering individuals to raise human rights claims for HIV prevention, treatment, and care. In the past 15 years, advocates have laid the groundwork on which a rapidly expanding enforcement paradigm has arisen at the intersection of human rights litigation and HIV/AIDS policy. As this enforcement develops across multiple countries, human rights are translated from principle to practice in the global response to HIV/AIDS, transforming aspirational declarations into justiciable obligations and implementing human rights through national policies and programs.

In 2007, there were 182,479 injury-related deaths in the United States — including homicides, suicides, and unintentional injuries – making injuries the leading cause of death for persons under age 45. Also in 2007, nearly 30 million Americans suffered a non-fatal injury serious enough to warrant hospital treatment. The lifetime cost of fatal and non-fatal injuries occurring in 2000 is estimated to exceed $400 billion.

Efforts to prevent injuries have often focused on changes to the built environment or potentially dangerous products to reduce risks. Building safety into a product or environment — especially in ways that require little or no user action to confer protection — is often more effective than trying to change consumer behavior. For example, improving the crashworthiness of cars through design changes such as air bags, fire-resistant fuel systems, or electronic stability programs, is more effective than simply trying to teach operators to become safer drivers.

A growing number of cities and counties have emerged as leaders in the fight against obesity in the United States and have enacted innovative policies to address this epidemic. Much of this local strategy focuses on how retail food establishments — namely, chain restaurants, corner stores, supermarkets, farmers markets, and mobile vendors – affect public health. Recognizing the enormous influence a community’s food environment has on the quality and quantity of what people eat, cities and counties have sought to encourage food retail establishments to promote healthier options through regulations and incentives.