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The Evolution of Law in Biopreparedness
Abstract
The decade following the terrorist attacks on September 11, 2001, and ensuing anthrax exposures that same fall has seen significant legal reforms designed to improve biopreparedness nationally. Over the past 10 years, a transformative series of legal changes have effectively (1) rebuilt components of federal, state, and local governments to improve response efforts; (2) created an entire new legal classification known as "public health emergencies"; and (3) overhauled existing legal norms defining the roles and responsibilities of public and private actors in emergency response efforts. The back story as to how law plays an essential role in facilitating biopreparedness, however, is pocked with controversies and conflicts between law- and policymakers, public health officials, emergency managers, civil libertarians, scholars, and others. Significant legal challenges for the next decade remain. Issues related to interjurisdictional coordination; duplicative legal declarations of emergency, disaster, and public health emergency; real-time legal decision making; and liability protections for emergency responders and entities remain unresolved. This article explores the evolving tale underlying the rise and prominence of law as a pivotal tool in national biopreparedness and response efforts in the interests of preventing excess morbidity and mortality during public health emergencies.
... [6][7][8][9] Four years later, Hurricane Katrina directed national focus to the response side and the unique challenges of caring for children during disasters. 1,[10][11][12] Countless children, many displaced from families, received medical care during Hurricane Katrina and in the days to weeks after its devastation. 6,13 Over the past decade, that experience has been memorialized to help us understand how disaster conditions alter the provision of medical care and create liability risks for providers who are working in those conditions. ...
... There are no comprehensive national liability protections for all health care providers during disasters. 10,25 Rather, many laws exist at the federal and state levels to reduce civil liability for certain health care practitioner categories by providing immunity against certain types of claims. 34,48 Table 1 provides a summary of existing federal legislation, and the following sections provide basic highlights of these laws and regulations. ...
... The National Disaster Medical System (NDMS) and the Medical Reserve Corp are responsible, during declared emergencies, for the mobilization and assignment of trained volunteers who are considered federal employees during their deployment. 10,41,53,81 The role of the NDMS is to provide civilian medical support to state and local governments for disaster victims through a national network of rapidly deployable medical teams. 41 The NDMS teams that provide general medical care are disaster medical assistance teams. ...
Although most health care providers will go through their careers without experiencing a major disaster in their local communities, if one does occur, it can be life and career altering. The American Academy of Pediatrics has been in the forefront of providing education and advocacy on the critical importance of disaster preparedness. From experiences over the past decade, new evidence and analysis have broadened our understanding that the concept of preparedness is also applicable to addressing the unique professional liability risks that can occur when caring for patients and families during a disaster. Concepts explored in this technical report will help to inform pediatric health care providers, advocates, and policy makers about the complexities of how providers are currently protected, with a focus on areas of unappreciated liability. The timeliness of this technical report is emphasized by the fact that during the time of its development (ie, late summer and early fall of 2017), the United States went through an extraordinary period of multiple, successive, and overlapping disasters within a concentrated period of time of both natural and man-made causes. In a companion policy statement (www.pediatrics.org/cgi/doi/10.1542/peds.2018-3892), recommendations are offered on how individuals, institutions, and governments can work together to strengthen the system of liability protections during disasters so that appropriate and timely care can be delivered with minimal fear of legal reprisal or confusion.
... According to Hodge (19), although legal reforms have occurred in the United States in the last years, three core challenges will continue to engage experts during the next decade: the legal implications of multiple emergency declarations, legal triage, and liability protection for practitioners and entities implementing crisis standards of care in response to declared emergencies (19). ...
... Epidemic scenarios that involve laws and PHLP concerning isolation, quarantine, and social distancing are worthy of broad attention. Limiting individual freedom in order to protect the public health has significant implications for managing infectious diseases (19,25,34,35). Preparing a legal infrastructure to administrate these situations is crucial, including declaration of an emergency situation which authorises public health officials to activate such means (19). ...
... Limiting individual freedom in order to protect the public health has significant implications for managing infectious diseases (19,25,34,35). Preparing a legal infrastructure to administrate these situations is crucial, including declaration of an emergency situation which authorises public health officials to activate such means (19). Nonetheless, operationalising them should not be based on legal facets alone, but should rather also consider judicial aspects. ...
Background: Public health legal preparedness (PHLP) for emergencies is a core component of the health system response. However, the implementation of health legal preparedness differs between low- and middle-income countries (LMIC) and developed countries. Objective: This paper examines recent trends regarding public health legal preparedness for emergencies and discusses its role in the recent Ebola outbreak. Design: A rigorous literature review was conducted using eight electronic databases as well as Google Scholar. The results encompassed peer-reviewed English articles, reports, theses, and position papers dating from 2011 to 2014. Earlier articles concerning regulatory actions were also examined. Results: The importance of PHLP has grown during the past decade and focuses mainly on infection–disease scenarios. Amid LMICs, it mostly refers to application of international regulations, whereas in developed states, it focuses on independent legislation and creation of conditions optimal to promoting an effective emergency management. Among developed countries, the United States’ utilisation of health legal preparedness is the most advanced, including the creation of a model comprising four elements: law, competencies, information, and coordination. Only limited research has been conducted in this field to date. Nevertheless, in both developed and developing states, studies that focused on regulations and laws activated in health systems during emergencies, identified inconsistency and incoherence. The Ebola outbreak plaguing West Africa since 2014 has global implications, challenges and paralleling results, that were identified in this review. Conclusions: The review has shown the need to broaden international regulations, to deepen reciprocity between countries, and to consider LMICs health capacities, in order to strengthen the national health security. Adopting elements of the health legal preparedness model is recommended.
... According to Hodge (19), although legal reforms have occurred in the United States in the last years, three core challenges will continue to engage experts during the next decade: the legal implications of multiple emergency declarations, legal triage, and liability protection for practitioners and entities implementing crisis standards of care in response to declared emergencies (19). ...
... Epidemic scenarios that involve laws and PHLP concerning isolation, quarantine, and social distancing are worthy of broad attention. Limiting individual freedom in order to protect the public health has significant implications for managing infectious diseases (19,25,34,35). Preparing a legal infrastructure to administrate these situations is crucial, including declaration of an emergency situation which authorises public health officials to activate such means (19). ...
... Limiting individual freedom in order to protect the public health has significant implications for managing infectious diseases (19,25,34,35). Preparing a legal infrastructure to administrate these situations is crucial, including declaration of an emergency situation which authorises public health officials to activate such means (19). Nonetheless, operationalising them should not be based on legal facets alone, but should rather also consider judicial aspects. ...
Background: Public health legal preparedness (PHLP) for emergencies is a core component of the health
system response. However, the implementation of health legal preparedness differs between low- and middleincome
countries (LMIC) and developed countries.
Objective: This paper examines recent trends regarding public health legal preparedness for emergencies and
discusses its role in the recent Ebola outbreak.
Design: A rigorous literature review was conducted using eight electronic databases as well as Google Scholar.
The results encompassed peer-reviewed English articles, reports, theses, and position papers dating from 2011
to 2014. Earlier articles concerning regulatory actions were also examined.
Results: The importance of PHLP has grown during the past decade and focuses mainly on infection�disease
scenarios. Amid LMICs, it mostly refers to application of international regulations,whereas in developed states,
it focuses on independent legislation and creation of conditions optimal to promoting an effective emergency
management. Among developed countries, the United States’ utilisation of health legal preparedness is the most
advanced, including the creation of a model comprising four elements: law, competencies, information, and
coordination. Only limited research has been conducted in this field to date.Nevertheless, in both developed and
developing states, studies that focused on regulations and laws activated in health systems during emergencies,
identified inconsistency and incoherence. The Ebola outbreak plaguing West Africa since 2014 has global
implications, challenges and paralleling results, that were identified in this review.
Conclusions: The review has shown the need to broaden international regulations, to deepen reciprocity
between countries, and to consider LMICs health capacities, in order to strengthen the national health
security. Adopting elements of the health legal preparedness model is recommended
... With regard to cybersecurity, increased support for overt counter-cyber activities and dedicated cybersecurity agencies (e.g., the governmental mitosis that first resulted in the National Security Agency and U.S. Cyber Command, and then other federal organizations, such as the Department of Homeland Security Cybersecurity and Infrastructure Security Agency, in the United States) may appear to be so large or prolific as to serve as deterrents, but it unclear how effective they will be (Nakashima, 2018). The Biological and Toxin Weapons Convention (Findlay, 2006), programs to control biological select agents (US Government Accountability Office, 2017), and laws and regulations prohibiting the use of biological material for crime, terrorism, and warfare (Hodge, 2012), create some barriers to misuse and establish some agreed upon national and international norms, but serve as imperfect deterrents in the biological arena. Deterrents and laws preventing malevolent cyberbio activity have not been legislated in many countries. ...
The cyber- and biological sciences are converging rapidly, creating benefits, new and advantageous applications, and increasing risks to all nations. The parts of the public and private sectors that should be responsible for cyberbiosecurity are not yet sufficiently organized or supported financially. This article addresses the need to ensure that national security policy: (1) assesses cyberbiological risk and incorporates deterrent and enforcement measures; (2) sets forth clear consequences for those individuals and countries that conduct cyberbiological attacks or otherwise compromise cyberbiosecurity, without imperiling the legitimate sharing of scientific data and information; (3) establishes voluntary cyberbiosecurity standards in partnership with the private sector; (4) identifies cyberbiosecurity threats, vulnerabilities, consequences, and solutions; and (5) results from the combined efforts of all branches of government and the private sector.
... In other instances, however, dual declarations may cause confusion if the laws supporting the declarations lack precision, the declarations contain redundant or overlapping language, or the declarations establish competing processes among different agencies for implementing the response. 31 ...
Disaster responses often involve coordination among multiple levels of government and public and private sector collaboration. When emergencies raise health concerns, governments must include public health and health care systems in their response.
A state government’s declaration of “public health emergency” can provide that state’s health sector with flexibility and guidance about response parameters. Although events including Hurricanes Katrina and Sandy and the H1N1 influenza outbreak provided opportunities for states to deploy their public health emergency powers, little has been reported about how states have used their authority to declare a public health emergency.
I present a systematic identification and analysis of states’ public health emergency declarations, examine why these declarations were issued, and discuss their potential value.
... Law plays an integral role in protecting the public's health and is inextricably linked to ethical considerations when considering emergency response willingness among local health department workers. [52][53][54][55][56][57] At the federal level, the US government's ability to respond to public health emergencies derives from several pieces of legislation, including the Robert T. Stafford Disaster Relief and Emergency Assistance Act 58 and the Public Health Services Act. 59 The Stafford Act grants the president the ability to declare an emergency or major disaster, generally as a response to a request from the governor of a state experiencing an emergency. ...
According to the Institute of Medicine, the local health department workforce is at the hub of the public health emergency preparedness system. A growing body of research has pointed to troubling attitudinal gaps among local health department workers, a vital response cohort, regarding willingness to respond to emergent infectious disease threats, ranging from naturally occurring pandemics to bioterrorism events. A summary of relevant literature on the empirical evidence, ethical norms, and legal standards applicable to the willingness of public health professionals to respond to an infectious disease emergency is presented. Recommendations are proposed for future work to be done to bring the relevant empirical, ethical, and legal considerations together to develop practical guidance for the local response to infectious disease emergencies.
... Since the terrorist attacks in fall 2001, emergency legal preparedness has been a dominant area of public health legal theory and practice. 22 Beyond the sheer number of related claims (164), however, is the breadth of specific requests. Leading themes include core guidance on: (1) the scope of emergency, disaster, and public health emergency declarations in response to diverse events ranging from pandemics to natural disasters; 23 (2) inter-jurisdictional coordination within and among governments responding to emergencies; (3) legal preparedness activities concerning implementation of crisis standards of care (as proposed by the Institute of Medicine in 2012); 24 (4) the use and deployment of health care workers via public and private sectors; and (5) balancing the interests of practitioners, patients, and entities concerning liability claims during emergencies. ...
Since its inception in September 2010, the Network for Public Health Law has responded to hundreds of public health legal technical assistance claims from around the country. Based on a review of these data, a series of major trends in public health practice and the law are analyzed, including issues concerning: the Affordable Care Act, tobacco control, emergency legal preparedness, health information privacy, food policy, vaccination, drug overdose prevention, sports injury law, public health accreditation, and maternal breastfeeding. These and other emerging themes in public health law demonstrate the essential role of law and practice in advancing the public's health.
Available through Cambridge Core here: https://www.cambridge.org/core/books/climate-change-public-health-and-the-law/D2DED4C703EBD2F8CBD5B302E0B7AA3B
The elderly are at greater risk of harm in disasters than younger adults, making it crucial for planners to provide proper assistance. Mistaken assumptions are associated with the impact of disasters on public health. Disaster planners and managers should be familiar with the myths and realities of the situation. Responses that are not based on an impartial evaluation contribute to the chaos. It is better to wait until real needs have been assessed. Preventing diseases requires improving sanitary conditions and educating the public. Reporters rely on information from victims, survivors, rescue workers, relief activists, and government officials. Training is crucial to the mitigation of mortality and morbidity. Disasters are unique and affect areas with different levels of vulnerability and with distinct social, health, and economic conditions with some similarities. During the post-disaster period, the major issue is defined as re-building the physical environment by emphasizing housing in the recovery program.
This paper examines the organization, services, and priorities of public health agencies and their capacity to be learning public health systems (LPHS). An LPHS uses data to measure population health and health risks and to evaluate its services and programs, and then integrates its own research with advances in scientific knowledge to innovate and improve its efficiency and effectiveness.
Public health agencies' (PHA) organizational characteristics vary across states, as does their funding per capita. Variations in organization, services provided, and expenditures per capita may reflect variations in community needs or may be associated with unmet needs. The status of legal statutes defining responsibilities and authorities and their relationships to other public and private agencies also vary. Little information is available on the efficiency and effectiveness of state and local PHAs, in part due to a lack of information infrastructure to capture uniform data on services provided. There are almost no data on the relationship of quality of services, staff performance, and resources to population health outcomes. By building a capacity to collect and analyze data on population health within and across communities, and by becoming a continuous learning PHA, the allocation of resources can more closely match population health needs and improve health outcomes. Accreditation of every PHA is an important first step toward becoming a learning PHA.
Public Health Services and Systems Research (PHSSR) is beginning to shed light on some of these issues, particularly by investigating variation across PHAs. As this emerging discipline grows, there is a need to enhance the collection and use of data in support of building organized, effective, and efficient LPHSs with the PHA capacity to continually improve the public's health.
Both naturally occurring disease and man-made outbreaks remain serious biological threats. In order to address these threats, the United States has developed a framework of biopreparedness that includes several bioresponse capabilities, one of which is medical countermeasures. No one in the fields of public health or biodefense would be surprised by the fact that the United States is unprepared to respond to a virus for which no medical countermeasures exist. Additionally, bioweapons made resistant to US medical countermeasures would also be catastrophic. This paper describes the biothreats to the United States today, the development of US biopreparedness, the weaknesses of medical countermeasure capabilities, and recommendations on how to improve this area of biopreparedness.
Law plays a critical role in all stages of a public health emergency, providing an infrastructure for planning, response, and recovery efforts. A growing body of research has underscored the potential for certain types of state laws, such as those granting liability protections to responders, to influence the public health workforce's participation in emergency responses. It is therefore especially important to focus on particular state-level laws that may be associated with individuals' increased or decreased willingness to respond. We conducted a systematic identification and analysis of specific state emergency preparedness laws that may affect individuals' willingness to respond and offer recommendations for policymakers seeking to promote more effective responses to public health emergencies.
The rapid spread of influenza during the 2012-13 season brought a series of public health challenges and corresponding response efforts. For decades, responses to annual flu have been undertaken routinely without extensive legal intervention. With the recent declaration of states of public health emergencies in Boston (January 9, 2013) and New York State (January 12, 2013), however, the legal baseline is changing. Propelled by a slate of state and local emergency declarations during the 2009-10 H1N1 pandemic, public officials are beginning to show cause for the issuance of formal emergency declarations in support of flu response efforts. The legal effects of these types of declarations are profound. Public and private actors are given significant, expedited public health powers. Scarce resources like vaccines can be more efficiently allocated. Laws relating to licensure, scope of practice, and liability can be effectively waived. Though originally conceptualized and once reserved for catastrophic, long-term health-related or bioterrorism events, public health emergency declarations are evolving to address temporary impacts on health care and public health services arising annually from flu outbreaks. This commentary explores the changing nature of public health emergencies and their current and potential impact on the provision of healthcare services in response to national or regional threats to the public's health.
Many experts predict the advent of a public health emergency resulting from a flu pandemic or bioterrorism attack in the foreseeable future. At the same time, many health care providers express significant concern about liability arising from emergency response activities, because it is unlikely that they would be able to provide optimal care in crisis conditions. They also state that this concern will likely influence their willingness to be involved in response activities. This article addresses issues that have received little attention in the legal literature: liability and immunity in public health emergencies. The article provides a first-of-its-kind comprehensive analysis of the different theories of liability that might be used by plaintiffs and the sources of immunity that are currently available to public health emergency responders. I will argue that the existing immunity scheme is a patchwork that leaves many gaps and unanswered questions. In particular, it largely excludes paid individual and corporate health care providers who may bear the greatest burden during a public health emergency as hundreds or thousands of patients simultaneously seek medical treatment. The specter of liability may induce these parties to refuse to participate in emergency response efforts, and thus, the unavailability of immunity could significantly compromise public welfare. Moreover, the risk of liability raises questions of justice because those that, unlike their more risk-averse counterparts, do treat patients, perhaps at great risk to their own health, would face potential liability rather than being rewarded for their altruism or professionalism. Consequently, the Article will craft recommendations for statutory reforms to remedy the piecemeal and deficient liability protection system that applies to health care providers responding to public health emergencies.
Similar to the triaging of patients by health care workers, legal and public health professionals must prioritize and respond to issues of law and ethics in declared public health emergencies. As revealed by the 2009-2010 H1N1 influenza outbreak and other events, there are considerable inconsistencies among professionals regarding how to best approach these issues during a public health emergency. Our project explores these inconsistencies by attempting to assess how practitioners make legal and ethical decisions in real-time emergencies to further critical public health objectives. Using a fictitious scenario and interactive visualization environment, we observed real-time decision-making processes among knowledgeable participants. Although participants' decisions and perspectives varied, the exercise demonstrated an increase in the perception of the relevance of legal preparedness in multiple aspects of the decision-making process and some key lessons learned for consideration in future repetitions of the exercise and actual, real-time emergency events.
( Disaster Med Public Health Preparedness . 2011;5:S242-S251)
Effective management of modern public health emergencies requires the coordinated efforts of multiple agencies representing various disciplines. Organizational culture differences between public health (PH) and emergency management (EM) entities may hinder inter-agency collaboration. We examine how PH and EM differ in their approach to PH law and how such differences affect their collaboration towards PH preparedness.
We conducted 144 semi-structured interviews with local and state PH and EM officials between April 2008 and November 2009. Thematic qualitative analysis in ATLAS.ti was used to extract characteristics of each agency's approach to PH legal preparedness.
Two conflicting approaches to the law emerge. The PH approach is characterized by perceived uncertainty regarding legal authority over preparedness planning tasks; expectation for guidance on interpretation of existing laws; and concern about individual and organizational liability. The EM approach reveals perception of broad legal authority; flexible interpretation of existing laws; and ethical concerns over infringement of individual freedoms and privacy.
Distinct interpretations of preparedness law impede effective collaboration for PH preparedness. Clarification of legal authority mandates, designation within laws of scope of preparedness activities and guidance on interpretation of current federal and state laws are needed.
Healthcare workers (HCWs) will play a key role in any response to pandemic influenza, and the UK healthcare system's ability to cope during an influenza pandemic will depend, to a large extent, on the number of HCWs who are able and willing to work through the crisis. UK emergency planning will be improved if planners have a better understanding of the reasons UK HCWs may have for their absenteeism, and what might motivate them to work during an influenza pandemic.This paper reports the results of a qualitative study that explored UK HCWs' views (n = 64) about working during an influenza pandemic, in order to identify factors that might influence their willingness and ability to work and to identify potential sources of any perceived duty on HCWs to work.
A qualitative study, using focus groups (n = 9) and interviews (n = 5).
HCWs across a range of roles and grades tended to feel motivated by a sense of obligation to work through an influenza pandemic. A number of significant barriers that may prevent them from doing so were also identified. Perceived barriers to the ability to work included being ill oneself, transport difficulties, and childcare responsibilities. Perceived barriers to the willingness to work included: prioritising the wellbeing of family members; a lack of trust in, and goodwill towards, the NHS; a lack of information about the risks and what is expected of them during the crisis; fear of litigation; and the feeling that employers do not take the needs of staff seriously. Barriers to ability and barriers to willingness, however, are difficult to separate out.
Although our participants tended to feel a general obligation to work during an influenza pandemic, there are barriers to working, which, if generalisable, may significantly reduce the NHS workforce during a pandemic. The barriers identified are both barriers to willingness and to ability. This suggests that pandemic planning needs to take into account the possibility that staff may be absent for reasons beyond those currently anticipated in UK planning documents. In particular, staff who are physically able to attend work may nonetheless be unwilling to do so. Although there are some barriers that cannot be mitigated by employers (such as illness, transport infrastructure etc.), there are a number of remedial steps that can be taken to lesson the impact of others (providing accommodation, building reciprocity, provision of information and guidance etc). We suggest that barriers to working lie along an ability/willingness continuum, and that absenteeism may be reduced by taking steps to prevent barriers to willingness becoming perceived barriers to ability.
The Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities drafted the Model State Emergency Health Powers Act (MSEHPA or Model Act) at the request of the Centers for Disease Control and Prevention. The Model Act provides state actors with the powers they need to detect and contain bioterrorism or a naturally occurring disease outbreak. Legislative bills based on the MSEHPA have been introduced in 34 states. Problems of obsolescence, inconsistency, and inadequacy may render current state laws ineffective or even counterproductive. State laws often date back to the early 20th century and have been built up in layers over the years. They frequently predate the vast changes in the public health sciences and constitutional law. The Model Act is structured to reflect 5 basic public health functions to be facilitated by law: (1) preparedness, comprehensive planning for a public health emergency; (2) surveillance, measures to detect and track public health emergencies; (3) management of property, ensuring adequate availability of vaccines, pharmaceuticals, and hospitals, as well as providing power to abate hazards to the public's health; (4) protection of persons, powers to compel vaccination, testing, treatment, isolation, and quarantine when clearly necessary; and (5) communication, providing clear and authoritative information to the public. The Model Act also contains a modernized, extensive set of principles and requirements to safeguard personal rights. Law can be a tool to improve public health preparedness. A constitutional democracy must balance the common good with respect for personal dignity, toleration of groups, and adherence to principles of justice.
Volunteer health professionals (VHPs) are essential in emergencies to fill surge capacity and provide needed medical expertise. While some VHPs are well-organized and trained, others arrive spontaneously at the site of a disaster. Lacking organization, training, and identification, they may actually impede emergency efforts. Complications involving medical volunteers in New York City after September 11, 2001, led Congress to authorize federal authorities to assist states and territories in developing emergency systems for the advance registration of volunteer health professionals (ESARVHP). Through advance registration, volunteers can be vetted, trained, and mobilized more effectively during emergencies. The use of VHPs, however, raises multiple legal questions: What constitutes an emergency, how is it declared, and what are the consequences? When are volunteers liable for their actions? When may volunteers who are licensed or certified in one state legally practice their profession in another state? Are volunteers entitled to compensation for harms they incur? This article examines the legal framework underlying the registration and use of volunteers during emergencies and offers recommendations for legal reform, including: (1) establish minimum standards to facilitate interjurisdictional emergency response, improve coordination, and enhance reciprocity of licensing and credentialing; (2) develop liability provisions for VHPs that balance their need to respond without significant fear of civil liability with patients' rights to legal recourse for egregious harms; and (3) provide basic levels of protections for VHPs harmed, injured, or killed while responding to emergencies.
Public health emergency preparedness and response have been defining goals in the United States since the terrorist and anthrax attacks in the fall of 2001. The objective of emergency preparedness is to improve the nation's ability to detect and respond to an array of public health emergencies including bioterrorism, emerging infectious diseases, and natural disasters. Despite progress toward this goal, the public is skeptical about the government's capabilities, fueled by the perceived lack of leadership and accountability following Hurricane Katrina.1 On December 19, 2006, President George W. Bush signed the Pandemic and All-Hazards Preparedness Act (PAHPA), which is intended to improve the organization, direction, and utility of preparedness efforts.2 PAHPA centralizes federal responsibilities, requires state-based accountability, proposes new national surveillance methods, addresses surge capacity, and facilitates the development of vaccines and other scarce resources.2 This act, however, raises important issues regarding federalism, evidence-based practice, privacy, volunteerism, and technological innovation.
When there is a catastrophe in the United States, state and local governments lead response activities, invoking state and local legal authorities to support these activities. When state and local response capabilities are overwhelmed, the President, acting through the Secretary of Homeland Security, can provide assistance to stricken communities, individuals, governments, and not-for-profit groups to assist in response and recovery. Aid is provided under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act) upon a presidential declaration. The Secretary of Health and Human Services (HHS) also has both standing and emergency authorities in the Public Health Service Act, by which he or she can provide assistance in response to public health and medical emergencies. At this time, however, the Secretary has limited means to finance activities that are ineligible, for whatever reason, for Stafford Act assistance. The flawed response to Hurricane Katrina, and preparedness efforts for an influenza ("flu") pandemic, have each raised concerns about existing federal response mechanisms for incidents that result in overwhelming public health and medical needs. These concerns include the delegation of responsibilities among different federal departments, and whether critical conflicts or gaps exist in these relationships. In particular, there are some concerns about federal leadership and delegations of responsibility as laid out in the recently published National Response Framework (NRF). There is no federal assistance program designed purposely to cover the uninsured or uncompensated costs of individual health care that may be needed as a consequence of a disaster, nor is there consensus that this should be a federal responsibility. Following Hurricane Katrina, Congress provided short-term assistance to host states, through the Medicaid program, to cover the uninsured health care needs of eligible Katrina evacuees. Some have proposed establishing a mechanism to cover certain uninsured health care costs of responders and others who are having health problems related to exposures at the World Trade Center site in New York City following the 2001 terrorist attack. Legislation introduced in the 110th Congress (H.R. 6569/S. 3312) would authorize the Secretary of HHS to use a special fund to provide temporary emergency health care coverage for uninsured individuals affected by public health emergencies. This chapter examines (1) the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies. A listing of federal public health emergency authorities is provided in the Appendix.
This book explores the current debates on global medical issues including national health care, experimental cancer drugs, quality of medicine and patient safety, preparation for a global flu pandemic, and regulating/outlawing cloning and germline genetic alterations. The book addresses national security issues concerning current national policies such as the best response to bioterrorism, force-feeding hunger strikers at Guantanamo, killing civilians in Afghanistan, with an emphasis on the roles played by physicians and lawyers in each.
The balance between individual interests and common goods needs to be recalibrated in an age of terrorism. Public health agencies should have a robust infrastructure to conduct essential public health services at a level of performance that matches evolving threats to the health of the public. This includes a well-trained workforce, electronic information, surveillance, and laboratory capacity. This paper explains modern efforts at public health law reform: a Model Public Health Statute and the Model State Emergency Health Powers Act (MSEHPA), which has been enacted wholly or in part by nineteen states and the District of Columbia. Next, the paper shows why existing public health laws provide a weak foundation for public health practice. Finally, the paper offers a systematic defense of MSEHPA, which has galvanized the public debate around the appropriate balance between public goods and individual rights.
During the fall of 2001, public health law scholars at the Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities were asked by the Centers for Disease Control and Prevention (CDC) and a series of national partners to develop the Model State Emergency Health Powers Act (MSEHPA). The MSEHPA provides a series of modern powers for states to consider in responding to catastrophic public health emergencies, including bioterrorism events. Since December 2001, provisions based on the MSEHPA have been introduced in nearly 40 states and passed in 20. Underlying the development of the act is a long-standing debate between legal and ethical scholars and law- and policymakers as to the appropriate ways to balance individual and communal rights. The drafting challenge was to create a comprehensive model law that provides adequate powers to protect the public's health while also respecting individual and group rights. The MSEHPA empowers public health agents with broad authority and simultaneously limits the exercise of power in time, duration, and scope to accomplish communal goals of abating serious public health threats. Coercive public health powers, particularly isolation and quarantine, are exercised on a temporary basis, only so long as are reasonably necessary and only among persons who justifiably may pose a risk to others because of their contagious conditions. Individual rights to contest the coercive use of public health powers, even during an emergency, are secured.
The September 11, 2001, terrorist attacks and the anthrax letters of 2001 were followed by a decade of major domestic and international disasters. Whether wrought by terrorist attacks, nuclear or chemical incidents, rapidly moving pandemics, record-breaking hurricanes, massive earthquakes, or other natural catastrophes, deadly disasters will continue to occur, and prompt and effective response will be required when lives are at stake.The good news is that disaster preparedness has improved during the past 10 years. For the health care community, 3 important developments are worth noting: (1) medical and public health professionals have joined the ranks of the disaster preparedness community; (2) the US federal government has increased its investment in preparedness, resulting in major improvements at the state and local levels; and (3) to an increasing extent, community participants who should be involved in disaster preparedness are getting involved.
Lawsuits against hospitals and other health care entities alleging liability for patient harms are brought and settled routinely in the United States. However, the settlement by health care giant Tenet Healthcare, on the eve of trial on March 23, 2011, in Preston v Tenet Healthsystem Memorial Medical Center,1 falls outside the norm of routine entity liability cases. The class of plaintiffs in New Orleans alleged not just that Tenet's emergency responses at its Memorial Medical Center during Hurricane Katrina were insufficient but that Tenet's failure to prepare for a foreseeable emergency caused their harms. Avoiding the prospect of a negative judgment at trial, Tenet's settlement implicates the increasing potential for health care entities to incur liability for deficiencies in emergency preparedness. It may renew demands to immunize entities from liability in future emergencies and requires a reassessment of the legal standard by which hospitals and other health care entities may be judged.
After 9/11, policy analysts speculated that clinicians may be reluctant to provide care during disasters because of fear of medical liability and proposed policies to create different standards of care for emergencies. In the context of the Haitian earthquake, the author argues that redefining the standard of care in disasters is neither necessary nor justified.
Legal preparedness is an essential component of effective public health emergency response, evinced recently by the numerous emergency declarations issued at the federal, state, and local levels to address the 2009 H1N1 influenza outbreak. Although the impact of these emergency laws at the federal and state levels has been studied extensively, the scope and role of local emergency laws have not been similarly assessed. In this article, we examine key issues of emergency laws among select US localities in the context of the recent H1N1 outbreak and their application to volunteer health professionals, who are often needed to meet patient surge capacity during local emergencies.
Localities represent the front line of emergency preparedness and must address an array of legal challenges before and during declared emergencies. Local legal preparedness differs based on overarching restrictions such as the degree of home rule provided to localities under state law. Some localities take innovative legal approaches to address emergency preparedness. Although beneficial in many respects, these variations add additional complexity to legal preparedness and intensify the need for predisaster planning, exercises, and coordination. ( Disaster Med Public Health Preparedness . 2009;3(Suppl 2):S176–S184)
According to many experts, a public health emergency arising from an influenza pandemic, bioterrorism attack, or natural disaster is likely to develop in the next few years. Meeting the public health and medical response needs created by such an emergency will likely involve volunteers, health care professionals, public and private hospitals and clinics, vaccine manufacturers, governmental authorities, and many others. Conducting response activities in emergency circumstances may give rise to numerous issues of liability, and medical professionals and other potential responders have expressed concern about liability exposure. Providers may face inadequate resources, an insufficient number of qualified personnel, overwhelming demand for services, and other barriers to providing optimal treatment, which could lead to injury or even death in some cases. This article describes the different theories of liability that may be used by plaintiffs and the sources of immunity that are available to public health emergency responders in the public sector, private sector, and as volunteers. It synthesizes the existing immunity landscape and analyzes its gaps. Finally, the authors suggest consideration of the option of a comprehensive immunity provision that addresses liability protection for all health care providers during public health emergencies and that, consequently, assists in improving community emergency response efforts.
The Medical Reserve Corps (MRC) is a key strategy used in the United States to assure an adequate surge capacity healthcare workforce for response to disasters. A survey of Hawaiian healthcare providers (n = 1,057) was conducted to identify factors that influence interest, ability, and willingness to join the MRC; 468 (44.3%) healthcare providers responded. Overall, females were more likely to demonstrate an interest in joining the MRC, while physicians and dentists reported lower levels of ability and willingness, in addition to a lower level of interest in joining the MRC than the other professional groups. The most important motivating factor in joining the MRC was altruism and the ability to help one's own community. Respondents reported a number of factors that would influence their decision to join or remain a MRC member. These included: (1) time commitment required; (2) MRC organization and management; (3) provision of MRC-sponsored training or education sessions and continuing education credits; (4) concerns regarding the safety of family members during a disaster; (5) professional liability protection for work performed during MRC operations; and (6) competing personal obligations. Strategies targeting these factors probably will be most effective in recruitment and retention of MRC volunteers as well as members of other public health surge capacity volunteer groups.
In the wake of the September 11, 2001, terrorist attacks, the Centers for Disease Control and Prevention proposed a model act for the states that specifies steps to be taken to contain an epidemic resulting from a bioterrorist attack. The act would grant broad powers to the states in the event of public health emergencies arising from bioterrorism. Annas discusses the trade-off between civil liberties and the need to protect the health of the public in the event of bioterrorism. His underlying premise is that the model act, despite being revised in December 2001, goes too far.
The balance between individual interests and common goods needs to be recalibrated in an age of terrorism. Public health agencies should have a robust infrastructure to conduct essential public health services at a level of performance that matches evolving threats to the health of the public. This includes a well-trained workforce, electronic information, surveillance, and laboratory capacity. This paper explains modern efforts at public health law reform: a Model Public Health Statute and the Model State Emergency Health Powers Act (MSEHPA), which has been enacted wholly or in part by nineteen states and the District of Columbia. Next, the paper shows why existing public health laws provide a weak foundation for public health practice. Finally, the paper offers a systematic defense of MSEHPA, which has galvanized the public debate around the appropriate balance between public goods and individual rights.
The Model State Emergency Health Powers Act became a contentious document in more than 30 states in 2001 and 2002. Controversy has focused on recommendations by the authors of the Model Act that seemed to accord higher priority to collective action in emergencies than to protecting privacy and property.
This situation has several causes that derive from the characteristics of public health emergencies during the past half century and the relative isolation of public health officials from both their colleagues in government and many members of the public.
To respond effectively to natural disasters and other public health emergencies, government resources must be augmented with the resources of volunteer organizations. Governmental actors are prepared to utilize volunteer health practitioners (VHPs) to meet patient surge capacity and provide essential public health services. However, difficult legal challenges arise regarding licensure, the scope of practice of volunteers, the relationship of volunteers to local healthcare delivery systems, disciplinary enforcement, the extent of exposure to civil liability, and how to provide compensation for volunteers injured or killed during disaster response activities. The Uniform Emergency Volunteer Health Practitioner Act (UEVHPA) seeks to address these problems and provide a better legal environment that facilitates VHPs efforts. This article discusses two important provisions of the UEVHPA, Section 11 which provides immunity against claims for negligence, under certain circumstances, for volunteers and organizations engaged in the deployment and use of volunteers, and Section 12 which provides workers' compensation benefits to VHPs when other sources of coverage are not available. Disaster relief organizations and healthcare provider organizations have consistently identified uncertainty and a lack of uniformity with respect to these issues as a major source of concern to volunteer practitioners and as a potential deterrent to their effective recruitment and utilization. Uniform state enactment of the UEVHPA would resolve many inconsistencies and gaps in the regulation and protection of VHPs across states.
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