IMPORTANCE: Associations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding. OBJECTIVE: To assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants. EXPOSURES: Maternal symptomatic or asymptomatic SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES: Infant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language. RESULTS: Among 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (β = 0.31; 95% CI, -2.97 to 3.58), gross motor (β = 0.82; 95% CI, -1.34 to 2.99), fine motor (β = 0.36; 95% CI, -0.74 to 1.47), expressive language (β = -1.00; 95% CI, -4.02 to 2.02), or receptive language (β = 0.45; 95% CI, -2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores. CONCLUSIONS AND RELEVANCE: In this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.

Air pollution is a known environmental health hazard. A major source of air pollution includes diesel exhaust (DE). Initially, research on DE focused on respiratory morbidities; however, more recently, exposures to DE have been associated with neurological developmental disorders and neurodegeneration. In this study, we investigated the effects of sub-chronic inhalation exposure to DE on neuroinflammatory markers in two inbred mouse strains and both sexes, including whole transcriptome examination of the medial prefrontal cortex. We exposed aged male and female C57BL/6J (B6) and DBA/2J (D2) mice to DE, which was cooled and diluted with HEPA-filtered compressed air for 2 h per day, 5 days a week, for 4 weeks. Control animals were exposed to HEPA-filtered air on the same schedule as DE-exposed animals. The prefrontal cortex was harvested and analyzed for proinflammatory cytokine gene expression (Il1ß, Il6, Tnfa) and transcriptome-wide response by RNA-seq. We observed differential cytokine gene expression between strains and sexes in the DE-exposed vs. control-exposed groups for Il1ß, Tnfa, and Il6. For RNA-seq, we identified 150 differentially expressed genes between air and DE treatment related to natural killer cell-mediated cytotoxicity per Kyoto Encyclopedia of Genes and Genomes pathways. Overall, our data show differential strain-related effects of DE on neuroinflammation and neurotoxicity and demonstrate that B6 are more susceptible than D2 to gene expression changes due to DE exposures than D2. These results are important because B6 mice are often used as the default mouse model for DE studies and strain-related effects of DE neurotoxicity warrant expanded studies.

Consumption of unpasteurised milk in the United States has presented a public health challenge for decades because of the increased risk of pathogen transmission causing illness outbreaks. We analysed Foodborne Disease Outbreak Surveillance System data to characterise unpasteurised milk outbreaks. Using Poisson and negative binomial regression, we compared the number of outbreaks and outbreak-associated illnesses between jurisdictions grouped by legal status of unpasteurised milk sale based on a May 2019 survey of state laws. During 2013-2018, 75 outbreaks with 675 illnesses occurred that were linked to unpasteurised milk; of these, 325 illnesses (48%) were among people aged 0-19 years. Of 74 single-state outbreaks, 58 (78%) occurred in states where the sale of unpasteurised milk was expressly allowed. Compared with jurisdictions where retail sales were prohibited (n = 24), those where sales were expressly allowed (n = 27) were estimated to have 3.2 (95% CI 1.4-7.6) times greater number of outbreaks; of these, jurisdictions where sale was allowed in retail stores (n = 14) had 3.6 (95% CI 1.3-9.6) times greater number of outbreaks compared with those where sale was allowed on-farm only (n = 13). This study supports findings of previously published reports indicating that state laws resulting in increased availability of unpasteurised milk are associated with more outbreak-associated illnesses and outbreaks.

This article outlines a pathway for public health departments and practitioners to incorporate law into their efforts to advance equity in health outcomes. We assert that examining and applying law can accelerate public health efforts to mitigate structural and systemic inequities, including racism. Recent events such as the COVID-19 pandemic and the community impacts of policing have brought into sharp relief the inequities faced by many populations. These stark and explosive examples arise out of long-standing, persistent, and sometimes hidden structural and systemic inequities that are difficult to trace because they are embedded in laws and accompanying policies and practices. We emphasize this point with a case study involving a small, majority Black community in semirural Appalachia that spent almost 50 years attempting to gain access to the local public water system, despite being surrounded by water lines. We suggest that public health practitioners have a role to play in addressing these kinds of public health problems, which are so clearly tied to the ways laws and policies are developed and executed. We further suggest that public health practitioners, invoking the 10 Essential Public Health Services, can employ law as a tool to increase their capacity to craft and implement evidence-based interventions.

Public health and law are inextricably intertwined. Law is the foundation of governmental public health practice, delineating the duties and authority to protect and promote conditions necessary for population health. 1 Law is also a social and structural determinant of health, because laws shape the physical, social, and economic environments that directly impact population health. 2 Public health laws at all levels of government enshrine public health strategies, are critical to addressing emerging issues, and are the means through which interventions are implemented and enforced.

Legal epidemiology” is the scientific study and deployment of law as a factor in the cause, distribution, and prevention of disease and injury in a population.1 Its emergence as a distinct field reflects the indispensability of law to modern public health practice.2–4 Proponents of the field aim to remove 2 persistent barriers to the effective use of legal action for public health: the limited extent of rigorous and timely evaluation of the impact of law and legal practices on health5,6; and the inattention in training and practice to the important legal functions played by nonlawyers in the health system.7,8 In the authors' assessment, the research necessary to identify and spread best legal practices is too often never carried out. Legal interventions affecting millions of Americans are often not evaluated for years, if at all. Innovations that show promise in research or practice are sometimes not scaled, so they either do not spread or spread too slowly. The unintended (or incidental) effects of laws on population health often remain unidentified and unexplored.2,9 Limited professional training in law, disciplinary boundaries, and, arguably, a cultural tension between law and other health disciplines continue to limit the full integration of law into public health.5–8,10 The publication of this special supplement of JPHMP is an opportune time to take stock. The purpose of this commentary is to describe the emergence of legal epidemiology, its key methods and tools, and the challenges it faces going forward.

BACKGROUND: The association between county-level social capital indices (SCIs) and the three most commonly reported sexually transmitted infections (STIs) in the United States is lacking. In this study, we determined and examined the association between two recently developed county-level SCIs (i.e., Penn State social capital index [PSSCI] vs. United States Congress social capital index [USCSCI]) and the three most commonly reported bacterial STIs (chlamydia, gonorrhea and syphilis) using spatial and non-spatial regression techniques. METHODS: We assembled and analyzed multi-year (2012-2016) cross-sectional data on STIs and two SCIs (PSSCI vs. USCSCI) on counties in all 48 contiguous states. We explored two non-spatial regression models (univariate and multiple generalized linear models) and three spatial regression models (spatial lag model, spatial error model and the spatial autoregressive moving average model) for comparison. RESULTS: Without exception, all the SCIs were negatively associated with all three STI morbidity. A one-unit increase in the SCIs were associated with at least 9% (p<0.001) decrease in each STI. Our test of the magnitude of the estimated associations indicated that the USCSCI was at least two-times higher than the estimates for the PSSCI for all STIs (highest p-value=0.01). CONCLUSIONS: Overall, our results highlight the potential benefits of applying/incorporating social capital concepts to STI control and prevention efforts. In addition, our results suggest that for the purpose of planning, designing and implementing effective STI control and prevention interventions/programs, understanding the communities' associational life (as indicated by the factors/data used to develop the USCSCI) may be important.

Knowledge of the law and its impact on health outcomes is increasingly important in public health practice. The CDC's Public Health Law Academy helps satisfy this need by providing online trainings, facilitator toolkits, and legal epidemiology tools to aid practitioners in learning about the law's role in promoting public health.

Emergency declarations are a vital legal authority that can activate funds, personnel, and material and change the legal landscape to aid in the response to a public health threat. Traditionally, declarations have been used against immediate and unforeseen threats such as hurricanes, tornadoes, wildfires, and pandemic influenza. Recently, however, states have used emergency declarations to address public health issues that have existed in communities for months and years and have risk factors such as poverty and substance misuse. Leaders in these states have chosen to use emergency powers that are normally reserved for sudden catastrophes to address these enduring public health issues. This article will explore emergency declarations as a legal mechanism for response; describe recent declarations to address hepatitis A and the opioid overdose epidemic; and seek to answer the question of whether it is appropriate to use emergency powers to address public health issues that are not traditionally the basis for an emergency declaration.

Legal Perspectives is aimed at informing healthcare providers, emergency planners, public health practitioners, and other decision makers about important legal issues related to public health and healthcare preparedness and response. The articles describe these potentially challenging topics and conclude with the authors' suggestions for further action. The articles do not provide legal advice. Therefore, those affected by the issues discussed in this column should seek further guidance from legal counsel. Readers may submit topics of interest to the column's editor, Lainie Rutkow, JD, PhD, MPH, at lrutkow@jhu.edu. Governors play a fundamental role in emergency preparedness and can help facilitate rapid responses to emergencies. However, laws that operate successfully under normal circumstances can inadvertently create barriers during emergencies, delaying a timely response. State laws could thus limit, or even prohibit, necessary response efforts. To combat this risk, legislatures have passed emergency powers laws in each state granting governors the authority to declare a state of emergency and to exercise certain emergency powers to meet the needs of the emergency. Researchers conducted a 50-state legal assessment, which identified and examined state laws that give governors the discretion to modify existing laws or create new laws to respond effectively to any type of declared emergency. This article outlines the findings of that assessment, which identified 35 states that explicitly permit governors to suspend or amend both statutes and regulations; 7 states in which governors are permitted to amend regulations during a declared emergency but are not explicitly authorized to modify or remove statutes; and 8 states and the District of Columbia that provide no explicit authority to governors to change statutes or regulations during a declared emergency. The article also provides examples of how this power has been used in the past to demonstrate the utility and scope of this authority in a variety of public health threats.

From 2004 to 2014, the incidence of neonatal abstinence syndrome (NAS) in the United States increased 433%, from 1.5 to 8.0 per 1,000 hospital births. The latest national data from 2014 indicate that one baby was born with signs of NAS every 15 minutes in the United States (1). NAS is a drug withdrawal syndrome that most commonly occurs among infants after in utero exposure to opioids, although other substances have also been associated with NAS. Prenatal opioid exposure has also been associated with poor fetal growth, preterm birth, stillbirth, and possible specific birth defects (2-5). NAS surveillance has often depended on hospital discharge data, which historically underestimate the incidence of NAS and are not available in real time, thus limiting states' ability to quickly direct public health resources (6,7). This evaluation focused on six states with state laws implementing required NAS case reporting for public health surveillance during 2013-2017 and reviews implementation of the laws, state officials' reports of data quality before and after laws were passed, and advantages and challenges of legally mandating NAS reporting for public health surveillance in the absence of a national case definition. Using standardized search terms in an online legal research database, laws in six states mandating reporting of NAS from medical facilities to state health departments (SHDs) or from SHDs to a state legislative body were identified. SHD officials in these six states completed a questionnaire followed by a semistructured telephone interview to clarify open-text responses from the questionnaire. Variability was found in the type and number of surveillance data elements reported and in how states used NAS surveillance data. Following implementation, five states with identified laws reported receiving NAS case reports within 30 days of diagnosis. Mandated NAS case reporting allowed SHDs to quantify the incidence of NAS in their states and to inform programs and services. This information might be useful to states considering implementing mandatory NAS surveillance.

OBJECTIVES: Gaps in vaccination coverage leave populations vulnerable to illnesses. Since the 1990s, there has been a growing movement to improve vaccination access by giving pharmacists the authority to administer vaccines according to state laws. Understanding the variation of pharmacist vaccination laws over time is critical to understanding the effect of improving access to vaccination services. METHODS: We identified relevant statutes and regulations with the use of Westlaw legal databases. A 4-stage coding process identified 220 legal variables of pharmacist vaccination authority. Each jurisdiction's laws were coded against these 220 legal variables. The resulting legal dataset was then evaluated to determine whether jurisdictions expanded or restricted pharmacist vaccination authorities over time. RESULTS: From 1971 to 2016, jurisdictions made 627 changes to statutes and regulations relating to pharmacist vaccination authority. There were 85 expansions, 3 restrictions, and 22 regulatory clarifications. Eight changes were deemed to be unclear, and 479 changes did not substantively alter the scope of pharmacist vaccination authority. CONCLUSION: Collectively, the laws in 50 states and DC paint a clear picture: the scope of pharmacists' vaccination authority is expanding. Jurisdictions are allowing pharmacists to administer more vaccines to younger patients with less direct prescriber oversight. This clear expansion of pharmacist vaccination authority stands in contrast to the reservations expressed by some physician groups for pharmacists as vaccination providers. However, laws in some states still do not permit pharmacists to vaccinate according to the Advisory Committee on Immunization Practices recommendations.

OBJECTIVES: In all health system sectors, electronic health information (EHI) is created, used, released, and reused. We examined states' efforts to address EHI uses in law to provide an understanding of the EHI legal environment. METHODS: Attorney researchers used WestlawNext to search for EHI-related statutes and regulations of the US states, US territories, and the District of Columbia in effect as of January 2014. The researchers independently catalogued provisions by the EHI use described in the law. Researchers resolved discrepancies through peer review meetings and recorded the consensus codes for each law. RESULTS: This study identified 2364 EHI-related laws representing 49 EHI uses in 54 jurisdictions. A total of 18 EHI uses were regulated by ≥10 jurisdictions. More than 750 laws addressed 2 or more EHI uses. Jurisdictions varied by the number of EHI laws in effect, with a mean of 44 laws. Texas had the most EHI laws (n = 145). Hawaii and South Carolina had the fewest (n = 14 each). CONCLUSIONS: The EHI legal landscape is complex. The large quantity and diversity of laws complicate legal analysis, likely delay implementation of public health solutions, and might be detrimental to the development of emerging health information technology. Research is needed to understand the effect of EHI-related laws.

The importance of legal epidemiology in public health law research has undoubtedly grown over the last five years. Scholars and practitioners together have developed guidance on best practices for the field, including: placing emphasis on transdisciplinary collaborations; creating valid, reliable, and repeatable research; and publishing timely products for use in decision-making and change. Despite the energy and expertise researchers have brought to this important work, they name significant challenges in marshalling the diverse skill sets, quality controls, and funding to implement legal epidemiology activities. The Centers for Disease Control and Prevention (CDC) has worked to develop cross-cutting research and translation on issues of national priority in legal epidemiology, and has explored ways to overcome some of these challenges. As such, this article describes a case study of the use of law to characterize states' prior authorization policies regarding medication used to treat attention-deficit/hyperactivity disorder (ADHD), a central component of a broader effort to improve behavior therapy options for young children with ADHD. This article highlights the types of legal epidemiology work we have undertaken, the application of this work to an emerging public health problem, and the lessons learned in creating impactful research for the field.

Despite benefits to sharing data among public health programs, confidentiality laws are often presumed to obstruct collaboration or data sharing. We present an overview of the use and release of confidential, personally identifiable information as consistent with public health interests and identify opportunities to align data-sharing procedures with use and release provisions in state laws to improve program outcomes. In August 2013, Centers for Disease Control and Prevention staff and legal researchers from the National Nurse-Led Care Consortium conducted a review of state laws regulating state and local health departments in 50 states and the District of Columbia. Nearly all states and the District of Columbia employ provisions for the general use and release of personally identifiable information without patient consent; disease-specific use or release provisions vary by state. Absence of law regarding use and release provisions was noted. Health departments should assess existing state laws to determine whether the use or release of personally identifiable information is permitted. Absence of direction should not prevent data sharing but prompt an analysis of existing provisions in confidentiality laws. (Am J Public Health. Published online ahead of print June 22, 2017: e1-e5. doi:10.2105/AJPH.2017.303862).

Mosquito-borne diseases are a threat globally and in the United States.1,2 For instance, in the United States, the West Nile virus first appeared in 1999 and has since spread throughout the country, causing >43 937 cases as of 2015.3 Recently, 2 other mosquito-borne diseases, dengue virus and chikungunya virus, were locally transmitted in the continental United States for the first time.4–7 Now, with the increase in Zika virus transmission—including 4752 travel-associated cases and 220 locally acquired cases in the United States as of February 7, 2017—public health officials face the challenge of instituting effective mosquito control programs and making decisions about pesticide use.8,9 | One question confronting public health officials is this: who has the legal authority for mosquito control in the United States, particularly for pesticide use and regulation? Is it the states or the federal government? The answer to this question is rooted in federalism, the scheme by which the legal authority is divided between the states and the federal government. By the earliest days of English colonial government in America, the colonies had inherited from the English King in Parliament their police powers, the natural plenary power of a sovereign state to regulate private interests for the public good, usually toward defending the health and welfare of their populations. When the Articles of Confederation were formed in 1781, the states were reluctant to give too many of these powers to a national government; thus, they retained individual authority to regulate all issues, except for a very few, including declaring war, trying pirates for crimes committed at sea, and conducting foreign policy and commerce. When the states met at the Constitutional Convention in 1787 to amend and improve the articles, they decided that a new national government was needed. The states ceded more authorities to the national government, and these authorities were expressly enumerated in article 1, section 8, of the US Constitution. These enumerated powers include, among others, the authority to raise taxes and regulate interstate commerce. The states retained all of the authority that they held prior to the US Constitution that was not expressly enumerated to the federal government. Later, in 1791, the Tenth Amendment to the Constitution recognized this reservation of authority: “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”10

It is easy to identify health laws that have helped Americans live longer, healthier lives. Indeed, most of the greatest public health accomplishments of the last century depended on legal action. The coordination of research, policy development, public education, and advocacy in the tobacco control movement shows that success is attainable even in the face of powerful industry opposition.1 The development of automobile safety laws during the past 30 years shows how well-conducted, properly diffused research can instigate policy cascades and guide policy refinement over time.2 These examples of “interventional health law”3—using law as a tool of intervention—also illustrate that developing, enacting, evaluating, and spreading health laws is not just the work of lawyers. In these and many examples like them, health advocates, researchers, public health practitioners, and lawyers work in strategic partnership to improve population health through law and policy. | Consistent with the literature on the art and science of evidence translation,4,5 these efforts were built on effective practices, such as cultivating partnerships among diverse stakeholders. These partnerships promote (1) research that is targeted at the most strategically relevant questions; (2) the development of model laws based on the best available science; (3) sophisticated community education and advocacy campaigns to win, defend, and enforce effective policies; and (4) enforcement to ensure that improved public health outcomes are achieved and sustained.6–8 The starting point for this commentary is that public health law is not just the work of lawyers but must also be owned by the range of public health disciplines as a transdisciplinary activity.9

CONTEXT: Daughters of women with polycystic ovary syndrome (PCOS) are thought to be at increased risk for developing stigmata of the syndrome, but the ontogeny during puberty is uncertain. OBJECTIVE: To phenotype daughters (N = 76) of mothers with PCOS and daughters (N = 80) from control mothers for reproductive and metabolic parameters characteristic of PCOS. DESIGN, SETTING, AND PARTICIPANTS: Matched Case/Control Study, Penn State Hershey Medical Center, Non-Hispanic, Caucasian girls age 4-17 INTERVENTION: Obtain birth history, biometric, ovarian ultrasounds, whole body DXA scan for body composition, 2 hour glucose challenged salivary insulin levels and two timed urinary collections (12 hours overnight and 3 hours AM) for gonadotropins and sex steroids. MAIN OUTCOME MEASURES: Main Endpoints: Integrated urinary levels of adrenal (DHEAS) and ovarian (Testosterone) steroids. Other endpoints: Integrated salivary insulin levels and urinary LH levels. RESULTS: There were no differences in detection rates or mean levels for gonadotropins and sex steroids in timed urinary collections between PCOS Daughters and Control Daughters, nor were there differences in integrated salivary insulin levels. 69% of Tanner 4/5 PCOS daughters vs. 31% of control daughters had hirsutism defined as a Ferriman-Gallwey score > 8 (P=0.04). There were no differences in body composition as determined by DXA between groups in the three major body contents, i.e. bone, lean body mass and fat, or in in ovarian volume between groups. CONCLUSIONS: Matched for pubertal stage, PCOS daughters have similar levels of urinary androgens and gonadotropins as well as glucose challenged salivary insulin levels.

Governments use statutes, regulations, and policies, often in innovative ways, to promote health and safety. Organizations outside government, from private schools to major corporations, create rules on matters as diverse as tobacco use and paid sick leave. Very little of this activity is systematically tracked. Even as the rest of the health system is working to build, share, and use a wide range of health and social data, legal information largely remains trapped in text files and pdfs, excluded from the universe of usable data. This article makes the case for the practice of policy surveillance to help end the anomalous treatment of law in public health research and practice. Policy surveillance is the systematic, scientific collection and analysis of laws of public health significance. It meets several important needs. Scientific collection and coding of important laws and policies creates data suitable for use in rigorous evaluation studies. Policy surveillance addresses the chronic lack of readily accessible, nonpartisan information about status and trends in health legislation and policy. It provides the opportunity to build policy capacity in the public health workforce. We trace its emergence over the past fifty years, show its value, and identify major challenges ahead.

Public health law has roots in both law and science. For more than a century, lawyers have helped develop and implement health laws; over the past 50 years, scientific evaluation of the health effects of laws and legal practices has achieved high levels of rigor and influence. We describe an emerging model of public health law that unites these two traditions. This transdisciplinary model adds scientific practices to the lawyerly functions of normative and doctrinal research, counseling, and representation. These practices include policy surveillance and empirical public health law research on the efficacy of legal interventions and the impact of laws and legal practices on health and health system operation. A transdisciplinary model of public health law, melding its legal and scientific facets, can help break down enduring cultural, disciplinary, and resource barriers that have prevented the full recognition and optimal role of law in public health. Expected final online publication date for the Annual Review of Public Health Volume 37 is March 17, 2016. Please see http://www.annualreviews.org/catalog/pubdates.aspx for revised estimates.

The 2014–2015 Ebola virus disease (Ebola) outbreak in West Africa is the largest in history, and as of October 4, 2015, had claimed 11,297 lives in Guinea, Liberia, and Sierra Leone (1). On August 7, 2014, CDC first posted guidance on monitoring and movement of persons who might have been exposed to Ebola virus to prevent the spread of Ebola into the United States. Since that time, the Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure (2) has been regularly updated based on the latest information available, most recently on May 13, 2015. On October 11, 2014, after the first case of Ebola was diagnosed in the United States, entry screening was implemented in five U.S. airports to identify travelers from countries with widespread Ebola transmission who might have been exposed to Ebola during the days before arrival or who had signs or symptoms of Ebola at the time of arrival (3). | On October 24, 2014, New York and New Jersey, both home to airports conducting entry screening, announced monitoring and movement policies for incoming travelers returning from Ebola-affected countries (4). The New York and New Jersey policies included mandatory quarantine for any person who had direct contact with a person with Ebola while in one of the Ebola-affected countries, including any medical personnel who had provided medical services for persons infected with Ebola, as well as active monitoring and possible quarantine for all persons with travel history to the affected countries, including those who had no direct contact with an infected person (4).

BACKGROUND: Healthcare-associated infections (HAIs) are preventable. Globally, laws aimed at reducing HAIs have been implemented. In the USA, these laws are at the federal and state levels. It is not known whether the state interventions are more effective than the federal incentives alone. OBJECTIVE: The aims of this study were to explore the impact federal and state HAI laws have on state departments of health and hospital stakeholders in the USA and to explore similarities and differences in perceptions across states. METHODS: A qualitative study was conducted. In 2012, we conducted semistructured interviews with key stakeholders from states with and without state-level laws to gain multiple perspectives. Interviews were transcribed and open coding was conducted. Data were analysed using content analysis and collected until theoretical saturation was achieved. RESULTS: Ninety interviews were conducted with stakeholders from 12 states (6 states with laws and 6 states without laws). We found an increase in state-level collaboration. The publicly reported data helped hospitals benchmark and focus leaders on HAI prevention. There were concerns about the publicly reported data (eg, lack of validation and timeliness). Resource needs were also identified. No major differences were expressed by interviewees from states with and without laws. CONCLUSIONS: While we could not tease out the impact of specific interventions, increased collaboration between departments of health and their partners is occurring. Harmonisation of HAI definitions and reporting between state and federal laws would minimise reporting burden. Continued monitoring of the progress of HAI prevention is needed.

Initial cases of Ebola in the U.S. raise varied legal issues as discussed at a late-breaking session at the 2014 Public Health Law conference. Session presenters share their perspectives on (1) state and local powers to quarantine and isolate persons, and (2) hospital preparedness underlying the treatment of Ebola patients.

BACKGROUND: Significant legal challenges arise when health-care resources become scarce and population-based approaches to care are implemented during severe disasters and pandemics. Recent emergencies highlight the serious legal, economic, and health impacts that can be associated with responding in austere conditions and the critical importance of comprehensive, collaborative health response system planning. This article discusses legal suggestions developed by the American College of Chest Physicians (CHEST) Task Force for Mass Critical Care to support planning and response efforts for mass casualty incidents involving critically ill or injured patients. The suggestions in this chapter are important for all of those involved in a pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS: Following the CHEST Guidelines Oversight Committee's methodology, the Legal Panel developed 35 key questions for which specific literature searches were then conducted. The literature in this field is not suitable to provide support for evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process resulting in seven final suggestions. RESULTS: Acceptance is widespread for the health-care community's duty to appropriately plan for and respond to severe disasters and pandemics. Hospitals, public health entities, and clinicians have an obligation to develop comprehensive, vetted plans for mass casualty incidents involving critically ill or injured patients. Such plans should address processes for evacuation and limited appeals and reviews of care decisions. To legitimize responses, deter independent actions, and trigger liability protections, mass critical care (MCC) plans should be formally activated when facilities and practitioners shift to providing MCC. Adherence to official MCC plans should contribute to protecting hospitals and practitioners who act in good faith from liability. Finally, to address anticipated staffing shortages during severe and prolonged disasters and pandemics, governments should develop approaches to formally expand the availability of qualified health-care workers, such as through using official foreign medical teams. CONCLUSIONS: As a fundamental element of health-care and public health emergency planning and preparedness, the law underlies critical aspects of disaster and pandemic responses. Effective responses require comprehensive advance planning efforts that include assessments of complex legal issues and authorities. Recent disasters have shown that although law is a critical response tool, it can also be used to hold health-care stakeholders who fail to appropriately plan for or respond to disasters and pandemics accountable for resulting patient or staff harm. Claims of liability from harms allegedly suffered during disasters and pandemics cannot be avoided altogether. However, appropriate planning and legal protections can help facilitate sound, consistent decision-making and support response participation among health-care entities and practitioners.

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.

Influenza A H1N1 2009 virus caused the first pandemic in an era when neuraminidase inhibitor antiviral drugs were available in many countries. The experiences of detecting and responding to resistance during the pandemic provided important lessons for public health, laboratory testing, and clinical management. We propose recommendations for antiviral susceptibility testing, reporting results, and management of patients infected with 2009 pandemic influenza A H1N1. Sustained global monitoring for antiviral resistance among circulating influenza viruses is crucial to inform public health and clinical recommendations for antiviral use, especially since community spread of oseltamivir-resistant A H1N1 2009 virus remains a concern. Further studies are needed to better understand influenza management in specific patient groups, such as severely immunocompromised hosts, including optimisation of antiviral treatment, rapid sample testing, and timely reporting of susceptibility results.

During the spring of 2009, a novel influenza A (H1N1) virus of swine origin caused human infection and acute respiratory illness in Mexico.1,2 After initially spreading among persons in the United States and Canada,3,4 the virus spread globally, resulting in the first influenza pandemic since 1968 with circulation outside the usual influenza season in the Northern Hemisphere (see the Supplementary Appendix, available with the full text of this article at NEJM.org). As of March 2010, almost all countries had reported cases, and more than 17,700 deaths among laboratory-confirmed cases had been reported to the World Health Organization (WHO).5 The number of laboratory-confirmed cases significantly underestimates the pandemic's impact. In the United States, an estimated 59 million illnesses, 265,000 hospitalizations, and 12,000 deaths had been caused by the 2009 H1N1 virus as of mid-February 2010.6 This article reviews virologic, epidemiologic, and clinical data on 2009 H1N1 virus infections and summarizes key issues for clinicians worldwide.