This symposium issue of the Journal of Law, Medicine & Ethics is devoted to the convening of the national public health law conference, Practical Approaches to Critical Challenges, on October 10-12, 2012, in Atlanta, Georgia. The conference was co-sponsored by the Network for Public Health Law and the American Society of Law, Medicine & Ethics (ASLME) with generous support provided by the Robert Wood Johnson Foundation, de Beaumont Foundation, California Endowment, and Healthcare Georgia Foundation.

With the support of those organizations and the dedicated efforts of the individuals mentioned below, the conference focused on building effective interactions between attorneys and public health practitioners in order to:

• • examine practical legal approaches to address priority public health issues;

• • learn about helpful public health law resources and evidence-based research;

• • discuss public health legal questions and answers; and

• • build partnerships to accomplish public health objectives and foster innovation.

BPA Production and Associated Health Risks Bisphenol A (BPA) is a chemical agent found in many everyday products, including canned goods and plastic food containers. BPA exposure is linked to a variety of adverse health effects, such as obesity and diabetes. To protect the public's health — especially the health of vulnerable fetuses, infants, children, and pregnant women — BPA regulations should encompass products intended specifically for these populations. Even with tremendous public outcry against the use of BPA, current federal restrictions do not reach far enough. The U.S. Food and Drug Administration (FDA) recently banned the use of BPA in children's sippy cups and baby bottles, but failed to address its inclusion in canned infant formula or plastic tableware.

BPA production began in the 1950s to make epoxy resins and was later employed to create polycarbonate plastic products.

It has now been 10 years since the framework for public health legal preparedness was put forth as a model to meet new public health challenges in the 21st century. Public health legal preparedness is defined as the “attainment by a public health system of specified legal of standards essential to the preparedness of the public health system.” The framework has continued to develop over time and four core elements have emerged to make up the basis for public health legal preparedness. The four core elements are: (1) laws and legal authorities; (2) competency in using laws effectively and wisely; (3) coordination of legally based interventions across jurisdictions and sectors; and (4) information on public health laws and best practices.

The Affordable Care Act (ACA) and other federal initiatives are fostering the emergence of a coherent vision for chronic disease prevention that has never before existed in the United States. This investment in population health and prevention comes not a moment too soon. Health care costs are proving very difficult to control and are rising at an unsustainable rate, driven in part by sky-rocketing chronic disease rates.

This article looks at how a health system can engage in prevention activities beyond the clinical setting and makes a strong case that these interventions will result in documented cost savings. We first examine an individually targeted strategy that helps patients obtain health insurance coverage. This strategy furthers a hospital's goal of receiving reimbursement for care while also having the social benefit of increasing patients’ economic stability.

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.

For at least the past 15 years, food safety stakeholders across all levels of government have recognized the critical role that state and local agencies play in our nation's food safety system. State and local agencies are the first responders to foodborne outbreaks and have primary responsibility for keeping their residents safe from foodborne disease through effective surveillance and rapid response to outbreaks. They also conduct the vast majority of food safety inspections across the nation's restaurants, grocery stores, and other food service and food retail establishments.

Recent efforts among industry and government officials alike have focused on creating a more integrated, prevention-oriented food safety system. The Food Safety Modernization Act, the first major overhaul of the nation's food safety laws since the 1930s, now mandates that most sectors of the food industry put preventive controls in place, changing the emphasis of what the FDA does from response to prevention.

Drug overdose has recently surpassed motor vehicle accidents to become the leading cause of unintentional injury death in the United States. The epidemic is largely driven by opioids such as oxycodone, hydrocodone, and methadone, which kill more Americans than heroin and cocaine combined. The demographics of overdose have changed over the past few decades as well: according to the latest data, the average overdose victim is now a non-Hispanic white man aged 45-54.

These deaths — over 16,000 per year — are almost entirely preventable. Opioid overdose kills by slowly depressing respiration, a process that can take several hours. It can be quickly and effectively reversed by the timely administration of naloxone, an opioid antagonist that works by displacing opioids from the brain receptors to which they attach, reversing their depressant effect. Naloxone, also known as Narcan, has many benefits and minimal risks. Although it is a prescription drug, it is not a controlled substance and has no abuse potential.

Even though health care provider reporting of diseases to public health authorities is common, often there is under-reporting by providers, including for notifiable diseases; frequently, under-reporting occurs by wide margins. Two causal factors for this under-reporting by providers have been that: (1) disclosing data may violate their patients’ privacy, and (2) disclosed data may be used to evaluate their performance. A reluctance to disclose information due to privacy concerns exists despite the U.S. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permitting disclosures of personal health information (PHI) for public health purposes without patient authorization. On the other hand, such patient privacy concerns are somewhat justified: there have been documented breaches of patient information from public health data custodians.

A common way to address this privacy issue is to de-identify patient data before it is disclosed to public health.

According to the Institute of Medicine, chronic pain affects at least 116 million adults in the United States (U.S.), which is more than the total affected by heart disease, cancer, and diabetes combined. Pain costs the nation up to $635 billion each year in medical treatment and lost productivity. It has been conceptualized as a public health problem due to its prevalence, seriousness, disparities, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. For many patients, treatment of pain is inadequate due to uncertain diagnoses, societal stigma, the lack of effective treatments, and inadequate patient and clinician knowledge about the best ways to manage pain. This article explores the inadequate treatment of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. This is followed by a review of the actions taken by states to regulate the prescribing of controlled substances.

Sugar consumption has long been linked with a host of chronic health problems, including obesity, diabetes, and cardiovascular disease. To reduce Americans’ intake, many have called for taxing sugary products or limiting access in certain environments like schools and workplaces. These sometimes controversial calls for new public policy to curb consumption may soon be eclipsed by newly emerging links between sugar and addiction.

Attaching the label “addictive” to a substance like sugar, which is necessary for human life, challenges widely held beliefs about addiction. But the extraordinary increase in sugar consumption during the past century, with related tripling of chronic diseases like obesity and diabetes, means our common understandings may be outdated.

Part I of this paper will define “addiction” — especially as it relates to what was once a naturally occurring food nutrient and now is a highly concentrated food additive — and present evidence of the addictive potential of sugar.

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.

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%).

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.

Despite spending more on health care than every other industrialized country, the U.S. ranks 37th in health outcomes. These differences cannot be explained away with differences in age and income, or even with quality of care. And, the rate of growth in health care spending in the U.S. continues to increase. The share of the Gross Domestic Product (GDP) attributable to health care grew from 9% in 1980 to more than 17% in 2011. Health care costs are projected to account for more than one-fifth of our economy by 2021. Despite spending more and more, the U.S. does not have better health outcomes than other countries. Worse, our increasing spending is largely attributable to preventable conditions. More than 85 cents of every dollar spent on health in the U.S. are spent on the treatment and management of chronic diseases, such as those caused by preventable conditions related to obesity and tobacco use.

During an emergency, laws serve crucial functions, including clarifying responsibilities, authorizing critical interventions, and protecting vulnerable populations. However, provisions of existing laws designed for normal, non-emergency circumstances may sometimes hinder emergency response efforts, thereby potentially endangering the public's health rather than protecting it. Pursuant to declared states of emergency, disaster, or public health emergency, however, the legal landscape changes in several important ways. Interventions not legally permissible under non-emergency circumstances become available. One key example is authority to temporarily waive legal provisions that may impede emergency response efforts, such as professional licensing requirements, facility capacity limitations, pharmaceutical pedigree obligations, and state contract restrictions, among other laws spanning a host of legal spheres.

This article examines the structure and use of waiver authority in emergencies. It provides recent examples of waivers and analyzes potential application to a hypothetical emergency scenario.

Congress implemented the Medicaid Act in 1965, acting pursuant to its Spending Clause authority to “provide for the…general Welfare.” Over time, the Act has been amended more than 50 times. Most recently, as part of the Patient Protection and Affordable Care Act (ACA), Congress required participating states to extend Medicaid eligibility to childless, non-disabled, and non-elderly adults with incomes below roughly 133% of the federal poverty level (referred to as childless adults).

Within hours of President Obama signing the ACA into law, four lawsuits were filed challenging the con-stitutionality of the ACA, including a case in Florida that eventually made its way to the Supreme Court as National Federal of Independent Business v. Sebelius (NFIB). As part of this case, officials from 26 states argued that Congress was improperly coercing them into participating in the Medicaid expansion.

When a disaster occurs, adults over age 65 may be disproportionately impacted due to sensory deficits, chronic health conditions, diminished social support and isolation, and financial limitations. Although older adults comprised approximately 15 percent of the New Orleans population, they accounted for over 70 percent of the fatalities associated with Hurricane Katrina in 2005. Disasters can also impact older adults’ morbidity, as a disaster may disrupt established habits and routines (e.g., timing of medication administration) and result in removal from a familiar environment, promoting disorientation. This may raise particular challenges for older adults with mental and physical co-morbidities, and subsequently for their formal and informal caregivers.

While some older adults may need care for physical health problems following a disaster, mental health needs are often overlooked or unmet. One study of Hurricane Katrina survivors found that, compared to older adults, middle-aged individuals were twice as likely to have received mental health services in the eight months after the hurricane.

The Second Amendment to the U.S. Constitution states: “A well regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed.” Until recently, no federal appellate court had ever struck down any gun law as a violation of the Second Amendment. In fact, even laws outlawing most handgun possession, or restricting other types of firearms, had been upheld, in part, because the laws did not interfere with the functioning of state militias.

Then, in 2008, the U.S. Supreme Court — for the first time in nearly 70 years — decided a case squarely addressing the meaning of the Second Amendment. In District of Columbia v. Heller, the Supreme Court concluded that the Second Amendment protected an individual right to own handguns in the home, invalidating a Washington, D.C. law.

But Heller left many issues undecided, including the precise scope of the Second Amendment.

In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line “New Yorkers need a Mayor, not a Nanny.” On television, the CATO Institute's Michael Cannon declared, “This is the most ridiculous sort of nanny state-ism; [i]t’s none of the mayor's business how much soda people are drinking.” And in newspapers around the country, editorial pages featured headlines such as “Gulp! Yet Another Intrusion of the Nanny State.” Just like that, the public debate about this measure became focused on government overreach, while the public health problem of obesity (and of overconsumption of soda in particular) faded into the background.