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Contents - JLME - 2013 Volume 41: 1 - Supplemental Issue
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. PREFACE: Thanking Those Who Made It Happen
Articles
  1. A New Approach for Regulating Bisphenol A for the Protection of the Public's Health
  2. Beyond Public Health Emergency Legal Preparedness: Rethinking Best Practices
  3. Doing Good and Doing Well: Corporate Social Responsibility in Post Obamacare America
  4. Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies
  5. Navigating the Legal Framework for State Foodborne Illness Surveillance and Outbreak Response: Observations and Challenges
  6. Changing Law from Barrier to Facilitator of Opioid Overdose Prevention
  7. Privacy and Anonymity Challenges When Collecting Data for Public Health Purposes
  8. State Laws Regulating Prescribing of Controlled Substances: Balancing the Public Health Problems of Chronic Pain and Prescription Painkiller Abuse and Overdose
  9. If Sugar Is Addictive... What Does It Mean for the Law?
  10. Practical, Ethical, and Legal Challenges Underlying Crisis Standards of Care
  11. Big Bad Data: Law, Public Health, and Biomedical Databases
  12. Using Public Health Legal Counsel Effectively: Beliefs, Barriers and Opportunities for Training
  13. Laboratory Specimens and Genetic Privacy: Evolution of Legal Theory
  14. Paying for Prevention: A Critical Opportunity for Public Health
  15. When Law Is Not Law: Setting Aside Legal Provisions during Declared Emergencies
  16. Implications of the Supreme Court's ACA Medicaid Decision
  17. Using the Law to Promote the Mental Health of Older Adults during Disasters
  18. Carrying Guns in Public: Legal and Public Health Implications
  19. Who's Your Nanny? Choice, Paternalism and Public Health in the Age of Personal Responsibility
Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF] (Free Download)
In October 2012, the American Society of Law, Medicine & Ethics and the Network for Public Health Law hosted the 2012 National Public Health Law Conference: Practical Approaches to Critical Challenges. Generously funded by the Robert Wood Johnson Foundation, the de Beaumont Foundation, the California Endowment, and the Healthcare Georgia Foundation, the conference engaged some of the country's leading health law practitioners and public health experts in discussing current and emerging topics in public health law.
Introductions
PREFACE: Thanking Those Who Made It Happen
Daniel D. Stier - [PDF] (Free Download)
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.
Articles
A New Approach for Regulating Bisphenol A for the Protection of the Public's Health
Leila Barraza - [PDF] (Free Download)
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.
Beyond Public Health Emergency Legal Preparedness: Rethinking Best Practices
Jennifer A. Bernstein - [PDF] (Free Download)
The concept of public health legal preparedness grew out of the public health emergency preparedness movement, but was conceptualized more broadly to be utilized to achieve full public health legal preparedness for all types of public health threats. This article analyzes the need to refocus public health legal preparedness to include all areas of public health law and presents a new model for the fourth core element that will aid in the development of legal benchmarks so public health systems can more effectively work towards attaining public health legal preparedness in all areas of public health practice.
Doing Good and Doing Well: Corporate Social Responsibility in Post Obamacare America
James Corbett and Manel Kappagoda - [PDF] (Free Download)
This paper looks how health systems can go beyond clinical care to address the social determinants of health and considers why this approach might be particularly relevant for Accountable Care Organizations (ACOs) touted by the Affordable Care Act. ACOs make profits by reducing the medical expenses of patient populations. The leading causes of death in the United States are tobacco use, insufficient physical activity, and an unhealthy diet. These risk factors are linked to increased incidence of a wide range of chronic diseases, the treatment of which places a tremendous financial burden on our health care system. Health care delivery and access are just a small part of the solution to our chronic disease crisis. Increasingly, strategies that address the social determinants of health - "the conditions into which people are born, grow, live, work, and age" - are the ones that hold the most promise. In Massachusetts, Steward Health Care System supports a number of initiatives to address the social determinants of health in its patient population. Steward provides an example of how a hospital system can address the health of its patient population by moving beyond clinical care. The varied initiatives have also resulted in cost savings for the system.
Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies
Brooke Courtney, Susan Sherman, and Matthew Penn - [PDF] (Free Download)
Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services' (HHS) Office of the General Counsel (OGC), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness (PREP) Act and Emergency Use Authorization (EUA) authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event (e.g., doxycycline mass dispensing preparedness for anthrax) and intra-event (e.g., 2009 H1N1 influenza pandemic response) activities.
Navigating the Legal Framework for State Foodborne Illness Surveillance and Outbreak Response: Observations and Challenges
Stephanie D. David and Rebecca L. Katz - [PDF] (Free Download)
Public health and food safety officials have long recognized the important role that state agencies play in protecting consumers from foodborne disease. With the increasing occurrence of multi-jurisdictional outbreaks, efforts have been underway to modernize and make more uniform the patchwork of state laws, protocols, and policies that exist across the U.S. for foodborne illness surveillance and outbreak response activities. To aid in this endeavor, and to better understand the role of law in a state's ability to carry out these functions effectively, we are creating a database of key legal authorities and provisions relating to foodborne illness surveillance and outbreak response across the 50 states and District of Columbia. There appears to be wide variation in the legal infrastructure for these activities, ranging from how certain terms are defined, to what and when foodborne illnesses must be reported, to which level of government has responsibility over investigation and response of foodborne outbreaks. As outbreaks become more widespread and involve multiple jurisdictions, it is important that public health and food safety stakeholders understand the legal authorities under which they operate, how such authorities may impede or promote efficient and effective surveillance and outbreak response, and use that knowledge to determine if state laws should be updated or strengthened.
Changing Law from Barrier to Facilitator of Opioid Overdose Prevention
Corey Davis, Damika Webb, and Scott Burris - [PDF] (Free Download)
Opioid overdose is the leading cause of accidental injury death in the United States, taking the lives of over 16,000 Americans every year. Many of those deaths are preventable through the timely provision of naloxone, a drug that reliably and effectively reverses opioid overdose. However, that drug is often not available where and when it is needed, due in large part to laws that pre-date the overdose epidemic. Preliminary evidence suggests that amending those laws to encourage the prescription and use of naloxone will reduce opioid overdose deaths, and a number of states have done so in the past several years. Since legal amendments designed to facilitate naloxone access have no documented negative effects, can be implemented at little or no cost, and have the potential to save both lives and resources, states that have not passed them may benefit from doing so.
Privacy and Anonymity Challenges When Collecting Data for Public Health Purposes
Khaled El Emam and Ester Moher - [PDF] (Free Download)
Two contemporary problems face public health professionals in collecting data from health care providers: the de-identification of geospatial information in a manner that still allows meaningful analysis, and ensuring that provider performance data (e.g., infection or screening rates) is complete and accurate. In this paper, we discuss new methods for de-identifying geographic information that will allow useful de-identified data to be disclosed to public health. In addition, we propose privacy preserving mechanisms that will likely encourage providers to disclose complete and accurate data. However, this must be accompanied by steps to grow trust between the providers and public health.
State Laws Regulating Prescribing of Controlled Substances: Balancing the Public Health Problems of Chronic Pain and Prescription Painkiller Abuse and Overdose
Andrea M. Garcia - [PDF] (Free Download)
Today, opiate-based prescription painkillers account for significant morbidity and mortality in the U.S. According to the Centers for Disease Control and Prevention, prescription painkiller overdose has reached epidemic proportions over the past decade. This article explores the focus on inadequate treatment of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. Since 2007, states have increasingly used their authority to address inappropriate prescribing. State strategies to address this complex problem have included: establishing and strengthening prescription drug monitoring programs, regulating pain management facilities, and establishing dosage thresholds above which a consult with a pain specialist is required. With chronic pain affecting at least 116 million adults in the United States, it will also be important to evaluate the impact these policies are having on legitimate access to pain care.
If Sugar Is Addictive... What Does It Mean for the Law?
Ashley Gearhardt, Michael Roberts, and Marice Ashe - [PDF] (Free Download)
Newly emerging links between sugar and addiction raise challenging issues for public health policy. What was once a naturally occurring food ingredient is now a highly concentrated food additive. If foods containing artificially high levels of sugar are capable of triggering addictive behaviors, how should policymakers respond? What regulatory steps would be suitable and practical? This paper explores the concept and definition of addiction and presents evidence of the addictive potential of sugar. It also explores the legal implications if sufficient evidence demonstrates that sugar is indeed addictive.
Practical, Ethical, and Legal Challenges Underlying Crisis Standards of Care
James G. Hodge, Jr., Dan Hanfling, and Tia P. Powell - [PDF] (Free Download)
Public health emergencies implicate difficult decisions among medical and emergency first responders about how to allocate essential resources. While various actors have proffered approaches on how to make these tough choices, meaningful guidance on shifting standards of care in major emergencies remained lacking. In March 2012, the Institute of Medicine (IOM) released additional guidance to assist facilities and practitioners to address scarce resource allocation through the development of "crisis standards of care" in catastrophes. As discussed in the article, identifying and resolving of complex practical, ethical, and legal challenges underlying real-time implementation of these standards are indispensable to protecting the public's health.
Big Bad Data: Law, Public Health, and Biomedical Databases
Sharona Hoffman and Andy Podgurski - [PDF] (Free Download)
The accelerating adoption of electronic health record (EHR) systems will 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. Because of clinicians' workloads, poor user-interface design, and other factors, EHR data can be erroneous, miscoded, fragmented, and incomplete. In addition, public health findings can be tainted by the problems of selection bias, confounding bias, and measurement bias. These flaws may become all the more troubling and important in an era of electronic "big data," in which a massive amount of information is processed automatically, without human checks. Thus, we conclude the paper by outlining several regulatory and other interventions to address data analysis difficulties that could result in invalid conclusions and unsound public health policies.
Using Public Health Legal Counsel Effectively: Beliefs, Barriers and Opportunities for Training
Nancy Kaufman, Susan Allan, and Jennifer Ibrahim - [PDF] (Free Download)
Effective use of public health law can be a powerful tool to advance the mission of public health departments to protect and promote the health of the population. However, there is little known about the way that public health officials think about law, use law, and/or interact with their legal counsel. The purpose of this paper is to examine some of the beliefs and barriers facing public health officials and legal counsel in their efforts to collaborate and to describe specific opportunities to better facilitate the use of law and collaboration, particularly in the area of training and education. Our findings are based on two studies: (1) a mixed methods study of state and local public health officials and their legal counsel, including surveys and qualitative interviews; and (2) a survey-based needs assessment of training for public health law. While state health officials and legal counsel view the role of public health law in similar ways, variation exists in organization, interactions and perceptions of collaboration on issues of public health law. Tremendous opportunity exists for improving collaboration between legal counsel and public health agencies through additional education and training opportunities. Improving the use of law in public health is possible - if practitioners and legal educators work together to fulfill its promise.
Laboratory Specimens and Genetic Privacy: Evolution of Legal Theory
Michelle Huckaby Lewis - [PDF] (Free Download)
Although laboratory specimens are an important resource for biomedical research, controversy has arisen when research has been conducted without the knowledge or consent of the individuals who were the source of the specimens. This paper summarizes the most important litigation regarding the research use of laboratory specimens and traces the evolution of legal theory from property claims to claims related to genetic privacy interests.
Paying for Prevention: A Critical Opportunity for Public Health
Jean C. O'Connor, Bruce J. Gutelius, Karen E. Girard, Danna Drum Hastings, Luci Longoria, and Melvin A. Kohn - [PDF] (Free Download)
Despite spending an increasing amount on health care and more than every other industrialized country, the U.S. ranks 37th in health outcomes. The implementation of the Patient Protection and Affordable Care Act (ACA) promises to ensure better access to health care for many Americans through expanded public and private insurance coverage, including basic preventive health care. Public health must seize this critical opportunity by taking steps to ensure that prevention, especially primary prevention, is embedded in our health system. This manuscript outlines four areas where public health officials across the U.S. can immediately capitalize on opportunities created by the ACA to ensure that prevention is a key component of health reform: (1) leading the way on community health assessments; (2) linking clinical and community prevention; (3) supporting the development of alternative payment methodologies to pay for prevention; and (4) serving as a community resource for the coordination of care and building the non-traditional health workforce.
When Law Is Not Law: Setting Aside Legal Provisions during Declared Emergencies
Daniel G. Orenstein - [PDF] (Free Download)
During an emergency, laws designed for normal operations and circumstances may sometimes hinder response efforts, potentially endangering the public's health rather than protecting it. Pursuant to declared states of emergency, however, officials may be authorized to waive or suspend some provisions of state law to address emergency conditions. Such authority can play a critical role in response efforts, but this authority varies significantly between states. States should carefully consider how their existing laws may affect response during a declared emergency and whether adoption of waiver authority would improve their legal structure. Where waiver provisions are in place, officials should ensure they understand its proper scope and utility.
Implications of the Supreme Court's ACA Medicaid Decision
Jane Perkins - [PDF] (Free Download)
In the typical case, states are expected to act like independent sovereigns and reject federal funding conditions they do not like. In National Federation of Independent Business v. Sebelius (NFIB), however, the Supreme Court found that Congress unduly coerced states when it enacted the Affordable Care Act's Medicaid expansion provision. This article provides an overview to NFIB and discusses its implications. Focusing on Chief Justice Roberts' plurality opinion, the article explains that undue coercion may occur when the following four elements come together: (1) Congress enacts a new spending program; (2) Congress seeks to induce state participation in the new program by threatening to terminate all federal funding to an existing program; (3) the federal funding to the existing program is significant; and (4) the requirements of the new program are not related to the old program and, thus, could not have been anticipated by the state.
Using the Law to Promote the Mental Health of Older Adults during Disasters
Lainie Rutkow, Jon S. Vernick, Adam P. Spira, and Daniel J. Barnett - [PDF] (Free Download)
Disasters may disproportionately impact older adults due to sensory deficits, diminished social support networks, financial limitations, and displacement from familiar environments. During and shortly after a disaster, older adults' mental health needs may be overlooked for varied reasons, including concerns about stigma and lack of information about available services. Law can protect the mental health of older adults in disaster and non-disaster circumstances, but it sometimes may frustrate efforts to address older adults' mental health concerns. This article analyzes three areas - Medicare services, staffing shortages, and continuity of prescription medications - in which the law has the potential to promote the mental health of older adults during disasters.
Carrying Guns in Public: Legal and Public Health Implications
Jon S. Vernick - [PDF] (Free Download)
In District of Columbia v. Heller, the U.S. Supreme Court ruled that the Second Amendment protects an individual's right to own handguns in the home for protection, invalidating a Washington, D.C. law banning most handgun possession. The Heller decision, however, provided lower courts with little guidance regarding how to judge the constitutionality of gun laws other than handgun bans. Nevertheless, lower courts have upheld the vast majority of federal, state, and local gun laws challenged since Heller. One area in which some lower courts have disagreed has been the constitutionality of laws regulating the ability to carry firearms in public. This issue may be the next to be addressed by the Supreme Court under its evolving Second Amendment jurisprudence. Courts should carefully consider the negative public health and safety implications of gun carrying in public as they weigh the constitutionality of these laws.
Who's Your Nanny? Choice, Paternalism and Public Health in the Age of Personal Responsibility
Lindsay F. Wiley, Micah L. Berman, and Doug Blanke - [PDF] (Free Download)
A belief that the government does (and should) have broad authority to protect and improve health, coupled with an understanding that collective action is often necessary to address public health challenges effectively, is central to the public health mindset. But many are questioning whether this vision of a strong government role is applicable to non-communicable disease threats and the social determinants of health. Arguments about public health paternalism are playing a role in political opposition to new law and policy interventions and in legal challenges aimed at striking down existing public health laws. This article explores the forces behind the cultural and political resonance of concerns about public health paternalism, "personal responsibility," and the "nanny state" and attempts to outlines a potential path forward from here.