Article

Law, Liability, and Public Health Emergencies

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Abstract

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.

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... During a pandemic, uncertainty surrounds the potential liability risks for HCWs, including claims of negligence, breaching the standards of care, constitutional claims, criminal liability, an invasion of privacy, breaching confidentiality, the appropriate allocation of resources, licensure issues, and the right to refuse to work during a pandemic. 2,3,5,6 HCWs seek legal protection, especially during PHE. Some of the proposals to address liability protection include providing immunity to emergency responders, legal waivers, and Good Samaritan laws. ...
... Legal immunity, for example, involves an exemption from a duty or liability. 5 Although some laws provide civil liability protection, criminal liability immunity is commonly absent from the law. Legal waivers in existing laws represent another liability protection instrument, which legalizes certain activities under specific conditions that are retrospectively judged, or even ignored altogether, so they are not a dependable tool for decision-making during crises. 1 Good Samaritan laws, however, also have severe limitations, as they are usually only applicable to those with unpaid positions or non-HCWs at the scene rather than being extended to hospital staff. ...
... Furthermore, some have argued that the standard of care is never fixed and that no single standard of care should be expected at all times. 5 Therefore, according to this argument, there is no altered standard of care. Owing to this ambiguity, many countries still lack legally binding regulations that might offer baseline protections for their activities. ...
Article
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The COVID-19 pandemic is the most unprecedented crisis facing modern healthcare governance in a century. Many healthcare activities are attracting scrutiny from ethical and legal perspectives. Therefore, healthcare professionals are concerned about legal ambiguity regarding legal liability and immunity in their areas of practice. Law is a key response activity that promotes a sense of safety and security among healthcare workers. This article describes why it is important formally to address issues of altered operations in healthcare practice during emergencies. Furthermore, this article provides suggestions regarding solutions to the issue of legal liability during disasters. Implementing ethical and legal clarity during disaster response is a necessity for a strong healthcare system at every level from international to local in order to achieve a stable healthcare workforce operating for the public good within a safe and secure working environment.
... 45 This has the potential to increase risk of being accused of negligence if the patient's outcome is negatively affected by the modified treatment. 48 A court may find liability against the provider if it determines that the provider had a duty to treat, that the duty was breached, that the breach resulted in harm, and that the harm can be linked to damages. 49 To determine that a breach occurred, the court must find that the provider failed to deliver care that a reasonable individual would have provided under similar circumstances. 2 When a disaster progresses to overwhelming conditions, practitioners face increased chances of an altered health care environment that will demand nonroutine actions. ...
... In truly extreme conditions, providers can face claims of gross negligence or actual criminal conduct while providing care. 48 Gross negligence is when negligent behavior is particularly egregious or reckless and closer to willful or wanton misconduct. 53 A criminal act can be practicing without a license (in addition to being a regulatory breach) or wantonly withholding or withdrawing treatment, thereby causing injury or death.* ...
... These types of allegations may arise in situations that are so extreme that providers facing them have no other available recourse when making decisions that would never be made under normal circumstances. 2 Examples of such situations are when providers are forced to remove a ventilator from 1 patient to give it to a patient who is more salvageable or to escalate parenteral pain medication for a patient who is critical with severe pain but has a high risk of respiratory depression. 24,45,48 These situations can occur because the environment of care is extremely compromised or has collapsed, giving providers no other options. Although less likely than other types of claims to arise from care provided during an extreme disaster, criminal claims are also less likely to be covered or indemnified by malpractice insurance. ...
Article
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.
... Liability protection is 1 of the primary concerns raised when responders consider the prospect of handling mass casualties with limited resources, as is likely to occur in an emergency following a nuclear detonation. 10,11 A variety of protections may be in place at the federal, state, and local levels. ...
... Thus, the legal standard of care can take into account the emergency conditions facing the provider, acknowledging that a reasonable provider may not be able to use normal standards of care in an emergency, and look to the medical standards that a reasonable provider would follow in those conditions. 10 State and local courts may compare what practitioners of the same specialty would do at the national level or what practitioners would do in the same or a similar local area. 12 States, tribes, and local governments may also choose to establish crisis standards of care. ...
... 17 In general, states have liability protections for state employees under tort liability acts. 10 Mutual aid compacts, such as the Emergency Management Assistance Compact (EMAC), may offer liability protection for state officers and employees when 1 state requests assistance from another. 10,17,18 Likewise, state governors may be able to extend liability protections under state law through emergency powers, generally following a declaration of an emergency, a public health emergency, a disaster, or a similar event. ...
Article
This article summarizes public health legal issues that need to be considered in preparing for and responding to nuclear detonation. Laws at the federal, state, territorial, local, tribal, and community levels can have a significant impact on the response to an emergency involving a nuclear detonation and the allocation of scarce resources for affected populations. An understanding of the breadth of these laws, the application of federal, state, and local law, and how each may change in an emergency, is critical to an effective response. Laws can vary from 1 geographic area to the next and may vary in an emergency, affording waivers or other extraordinary actions under federal, state, or local emergency powers. Public health legal requirements that are commonly of concern and should be examined for flexibility, reciprocity, and emergency exceptions include liability protections for providers; licensing and credentialing of providers; consent and privacy protections for patients; occupational safety and employment protections for providers; procedures for obtaining and distributing medical countermeasures and supplies; property use, condemnation, and protection; restrictions on movement of individuals in an emergency area; law enforcement; and reimbursement for care. ( Disaster Med Public Health Preparedness . 2011;5:S65-S72)
... The professional would therefore be exempted from any compensation obligation pursuant to Articles 1218 and 1256 of the civil code. These laws are more easily applied within the context of personal liability as opposed to the liability of facilities, which are obliged to demonstrate their inability to fulfill their duties due to (objectively) unpredictable and unavoidable causes [29,30], to a crisis and to an inability to ensure the standard of care previously delivered [31][32][33][34][35]. To that end, Article 2236 of the civil code may be invoked, which sanctions that "If performing the service requires the solution to particularly difficult technical problems, the service provider is not liable for damages in the absence of malicious misconduct or gross negligence." ...
Article
Full-text available
The World Health Organization (WHO) declared the outbreak of the Coronavirus disease-2019 (COVID-19) infection a pandemic on 11 March 2020. As of the end of October 2020, there were 50 million cases of infection and over one million deaths recorded worldwide, over 45,000 of which occurred in Italy. In Italy, the demand for intensive care over the course of this pandemic crisis has been exceptionally high, resulting in a severe imbalance between the demand for and availability of the necessary resources. This paper focuses on elements of preventive medicine and medical treatments in emergency and non-emergency situations which, based on the international scientific literature, may prove to be useful to physicians on a behavioral level and avert professional liability problems. In order to achieve this objective, we have performed a search on MEDLINE to find published articles related to the risks associated with the pandemic that contain useful suggestions and strategies for mitigating risks and protecting the safety of the population. The results have been collocated in line with these specific study areas.
... During an emergency, the conduct of healthcare professionals should not be judged by courts as it would be under ordinary circumstances. Some experts have used the terminology "altered standards of care" when proposing medical practice guidelines for public health emergencies [2]. Similarly, courts should likewise use "altered standards of evaluation" when they judge the conduct engaged in by a healthcare professional during an emergency crisis. ...
Article
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In the context of the COVID-19 pandemic, it is important not to forget, when the emergency is controlled or even over, that those who today are defined in all Countries as “heroes” could in the future be called to answer for alleged damage from professional liability. It is necessary to be prepared, both as health professionals and from a legal and governmental point of view, for a surge of professional liability claims which, with high probability, will begin to emerge in the coming months.
... 27 In crises, it is exceedingly difficult for HCWs to withhold laudable treatment of any patient, 28 much less to make such decisions under the threat of future liability. 29 As a result, explicit liability protections for HCWs regarding acts of ordinary negligence in crises are merited. 30 Still, what if the very foundation for making critical choices in crisis was later demonstrated through observation or research to lack efficacy? ...
... Options include granting sovereign immunity to all medical personnel and increasing the agreed upon standard for malpractice claims from simple negligence to reckless indifference. [473,474] National and international specialty organizations must advocate for an equitable legal framework to protect physicians practicing on the COVID-19 frontlines. ...
Article
Full-text available
What started as a cluster of patients with a mysterious respiratory illness in Wuhan, China, in December 2019, was later determined to be coronavirus disease 2019 (COVID‑19). The pathogen severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), a novel Betacoronavirus, was subsequently isolated as the causative agent. SARS‑CoV‑2 is transmitted by respiratory droplets and fomites and presents clinically with fever, fatigue, myalgias, conjunctivitis, anosmia, dysgeusia, sore throat, nasal congestion, cough, dyspnea, nausea, vomiting, and/or diarrhea. In most critical cases, symptoms can escalate into acute respiratory distress syndrome accompanied by a runaway inflammatory cytokine response and multiorgan failure. As of this article’s publication date, COVID‑19 has spread to approximately 200 countries and territories, with over 4.3 million infections and more than 290,000 deaths as it has escalated into a global pandemic. Public health concerns mount as the situation evolves with an increasing number of infection hotspots around the globe. New information about the virus is emerging just as rapidly. This has led to the prompt development of clinical patient risk stratification tools to aid in determining the need for testing, isolation, monitoring, ventilator support, and disposition. COVID‑19 spread is rapid, including imported cases in travelers, cases among close contacts of known infected individuals, and community‑acquired cases without a readily identifiable source of infection. Critical shortages of personal protective equipment and ventilators are compounding the stress on overburdened healthcare systems. The continued challenges of social distancing, containment, isolation, and surge capacity in already stressed hospitals, clinics, and emergency departments have led to a swell in technologically‑assisted care delivery strategies, such as telemedicine and web‑based triage. As the race to develop an effective vaccine intensifies, several clinical trials of antivirals and immune modulators are underway, though no reliable COVID‑19‑specific therapeutics (inclusive of some potentially effective single and multi-drug regimens) have been identified as of yet. With many nations and regions declaring a state of emergency, unprecedented quarantine, social distancing, and border closing efforts are underway. Implementation of social and physical isolation measures has caused sudden and profound economic hardship, with marked decreases in global trade and local small business activity alike, and full ramifications likely yet to be felt. Current state‑of‑science, mitigation strategies, possible therapies, ethical considerations for healthcare workers and policymakers, as well as lessons learned for this evolving global threat and the eventual return to a “new normal” are discussed in this article. Keywords: 2019‑nCoV, coronavirus, COVID‑19, global impact, International Health Security, pandemic, severe acute respiratory syndrome coronavirus 2
... Accurate transmission of information is vital; translation should be fast and reliable to minimize the potential for *Address correspondence to this author at the WHO Collaborating Center on Prevention and Treatment of Human Echinococcosis; Parasitology Dept., CHRU Jean Minjoz, 25030, Besançon, France; Tel/Fax: + 33 6 08 02 47 96; E-mail: dvuitton@univ-fcomte.fr hazards. Any ambiguity and unresolved complexity in the words and sentences used in the communication among professionals, as well as between professionals and the general public, can not only interfere with clear comprehension, but also generate safety and liability issues [1]. Emerging and re-emerging pandemics for instance are health issues which may have a worldwide impact [2][3][4] and therefore must be communicated accurately across national boundaries. ...
Article
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Any ambiguity in texts used in the communication about vaccines can not only interfere with comprehension, but also generate safety and liability issues. Within a survey on the quality of written protocols for at-risk interventional procedures and sanitary crises, we analyzed documents relating to vaccination, and among them, the "package-leaflet" of an anti-H1N1 influenza vaccine, widely disseminated to the public in 2009-2010. Among the most common mistakes, we observed that 1) language was not always adjusted to the non-specialist's level of knowledge; 2) chronology, logic, consistency, and homogeneity were often missing; 3) crucial pieces of information were disseminated all over the text, 4) use of the passive voice did not distinguish between instructions and information; 5) use of synonyms could be misleading and impair translation. We propose the use of "Controlled language" (CL) to improve the situation. By constraining lexicon, grammar and syntax, CL is a way to write documents that are clear, accurate and devoid of ambiguity. However, the set of rules necessary to write in CL is difficult to memorize. We thus developed authoring software (Redacticiel Prolipsia) to make the creation of a CL by linguists and its use by health professionals easy and adapted to any domain. It may considerably improve the writing of vaccine package inserts/leaflets. It could be used to write information documents about vaccines and their safety, and operating procedures for professionals to prepare, store, and administer vaccines, decide upon proper indication of vaccines, and follow patients after vaccine injection.
... Consequently, law enforcement authorities and people who are injured or their survivors may seek to hold responders legally liable for their actions and to obtain redress. 57 Planning ahead to ensure that the legal environment will support an effective, fair, and consistent response is a crucial step in preparing for crisis standards of care during an emergency. 21 Mechanisms should be in place to allow waiver or suspension of certain legal requirements and regulations following emergency declaration so as to ensure a legal environment that is facilitative and not burdensome or a hindrance to surge responses. ...
Article
When medical and health needs of a disaster-stricken population exceed currently available resources, surge capacity must be created. The 3S Surge System consists of staff (personnel), stuff (supplies and equipment), and structure (physical location and incident management). Because it is not feasible to deliver health care in the usual way during a catastrophe, the goal shifts from optimizing individual to maximizing population medical and health outcomes. Allocation of scarce resources requires an evidence-based approach that encompasses national and international standards while maintaining regional and local flexibility. At some point in time following a catastrophe, it may become imperative to implement a crisis standard of care putting protocols, such as rationing of health care supplies and medications into action. In developing and defining this crisis standard of care, there are a multiple considerations, including medical, ethical, legal, and implementation/deactivation procedures. This manuscript reviews the origin of the concept of crisis standard of care with a discussion of its development, changes in health care delivery goals during emergencies, when to adopt crisis care policies and protocols, issues to address in catastrophic disaster planning, ethical and legal considerations, and directions for future research.
... 13 Emergency declarations trigger an array of special powers that are designed to facilitate response efforts through public and private sectors. Depending on the level and type of emergency declared, emergency laws offer government and the private sector flexible powers to respond, encourage response efforts by limiting liability, 14,15 and help support crisis standards of care 1,16 and alterations to professional scopes of practice. 17 Although they are a critical component of disaster responses, emergency laws do not always facilitate best practices in the allocation of scarce resources. ...
Article
Full-text available
Effective emergency response among hospitals and other health care providers stems from multiple factors depending on the nature of the emergency. While local emergencies can test hospital acute care facilities, prolonged national emergencies, such as the 2009 H1N1 outbreak, raise significant challenges. These events involve sustained surges of patients over longer periods and spanning entire regions. They require significant and sustained coordination of personnel, services, and supplies among hospitals and other providers to ensure adequate patient care across regions. Some hospitals, however, may lack structural principles to help coordinate care and guide critical allocation decisions. This article discusses a model Memorandum of Understanding (MOU) that sets forth essential principles on how to allocate scarce resources among providers across regions. The model seeks to align regional hospitals through advance agreements on procedures of mutual aid that reflect modern principles of emergency preparedness and changing legal norms in declared emergencies. ( Disaster Med Public Health Preparedness . 2011;5:54-61)
... Many of them, written by American and British authors, deal with ethical and legal problems. [46][47][48][49] One problem for legal examination is the difference between Anglo-American and Scandinavian legal systems. In addition, the contents of national laws and regulations are different. ...
Article
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The 2009 influenza A/H1N1 pandemic seems to be only moderately severe. In the future, a pandemic influenza with high lethality, such as the Spanish influenza in 1918-1919 or even worse, may emerge. In this kind of scenario, lethality rates ranging roughly from 2% to 30% have been proposed. Legal and ethical issues should be discussed before the incident. This article aims to highlight the legal, ethical and professional aspects that might be relevant to anaesthesiologists in the case of a high-lethality infectious disease such as a severe pandemic influenza. The epidemiology, the role of anaesthesiologists and possible threats to the profession and colleagueship within medical specialties relevant to anaesthesiologists are reviewed. During historical plague epidemics, some doctors have behaved like 'deserters'. However, during the Spanish influenza, physicians remained at their jobs, although many perished. In surveys, more than half of the health-care workers have reported their willingness to work in the case of severe pandemics. Physicians have the same human rights as all citizens: they have to be effectively protected against infectious disease. However, they have a duty to treat. Fair and responsible colleagueship among the diverse medical specialties should be promoted. Until disaster threatens humanity, volunteering to work during a pandemic might be the best way to ensure that physicians and other health-care workers stay at their workplace. Broad discussion in society is needed.
... Sharona Hoffman's study finds that US liability law is a patchwork with many gaps and inconsistencies that do not always protect health care providers during emergencies. 3 Hospitals or clinics that donate their time, space, supplies, and resources to emergency response efforts and individual responders who continue to receive salaries from their employers are at the greatest risk. ...
Article
Emergency Response and Liability Laws - Volume 3 Issue 2 - Nancy H. Nielsen
... The policy recommendations proposed by Gebbie et al seeking to limit the liability of health care providers are also consistent with the findings of a study by Hoffman et al in this issue. 3 The article describes the concepts of liability and standards of care and analyzes the various liability protections and sources of immunity available to emergency responders. In legal terms, the standard of care is defined as what a reasonable practitioner would do under similar circumstances. ...
Article
Numerous catastrophic events in the 21st century have motivated renewed discussion regarding whether the traditional definition of standard of care appropriately applies to clinical decision-making in crisis scenarios. Some authorities have proposed the adoption of a crisis standard of care, which refines physician responsibilities during a crisis event in accordance with population health principles. However, this proposal is fraught with controversy, and current medical and legal scholarship on this topic remains complex and conflicted. To clarify these points and provide practicing neurosurgeons with guidance, we provide a review of current literature on the evolving definitions of crisis standard of care. Additionally, we provide an assessment of the implications of a crisis standard of care, as it relates to legal liability, clinical ethics, and neurosurgical practice.
Article
During disaster response and recovery, legal issues often arise related to the provision of health care services to affected residents. Superstorm Sandy led to the evacuation of many hospitals and other health care facilities and compromised the ability of health care practitioners to provide necessary primary care. This article highlights the challenges and legal concerns faced by health care practitioners in the aftermath of Sandy, which included limitations in scope of practice, difficulties with credentialing, lack of portability of practitioner licenses, and concerns regarding volunteer immunity and liability. Governmental and nongovernmental entities employed various strategies to address these concerns; however, legal barriers remained that posed challenges throughout the Superstorm Sandy response and recovery period. We suggest future approaches to address these legal considerations, including policies and legislation, additional waivers of law, and planning and coordination among multiple levels of governmental and nongovernmental organizations. ( Disaster Med Public Health Preparedness . 2016;page 1 of 7)
Article
Over the past decade, preparedness efforts have increased in response to real and potential threats. One prominent issue is health professional's scope of practice - both as a potential limiting factor (state licensure limitations) and as a possible solution to health professional shortages during a public health emergency.This article provides an overview of nursing regulation during public health emergencies. Many nurses are quick to volunteer during an emergency; being prepared in advance will help the overall response effort.
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To describe hospitals' perceptions of the New York City Medical Reserve Corps (NYC MRC); clarify administrative, legal, and clinical obstacles to the use of NYC MRC volunteers; and identify possible strategies to overcome these barriers. We administered an informational questionnaire to 33 NYC hospitals and conducted 2 facilitated discussion groups comprising 62 hospital representatives. The most commonly reported hospital barriers to the use of MRC volunteers were concerns about the clinical competence of the volunteers, their lack of familiarity with medical technology used clinically in a hospital setting, and the potential for institutional liability. Although the NYC MRC has the potential to assist the health care system in the event of a disaster, NYC hospitals will need clarification of the clinical and legal issues involved in the use of MRC volunteers for patient care. (Disaster Med Public Health Preparedness. 2015;0:1-5).
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On October 29, 2012, Hurricane Sandy made landfall in the neighborhood of Red Hook in Brooklyn, New York. The massive tidal surge generated by the storm submerged the coastal area, home to a population over 11,000 individuals, including the largest public housing development in Brooklyn. The infrastructure devastation was profound: the storm rendered electricity, heat, water, Internet, and phone services inoperative, whereas local ambulatory medical services including clinics, pharmacies, home health agencies, and other resources were damaged beyond functionality. Lacking these services or lines of communication, medically fragile individuals became isolated from the hospital and 911-emergency systems without a preexisting mechanism to identify or treat them. Medically fragile individuals primarily included those with chronic medical conditions dependent on frequent and consistent monitoring and treatments. In response, the Red Hook community established an ad hoc volunteer medical relief effort in the wake of the storm, filling a major gap that continues to exist in disaster medicine for low-income urban environments. Here we describe this effort, including an analysis of the medically vulnerable in this community, and recommend disaster risk reduction strategies and resilience measures for future disaster events. ( Disaster Med Public Health Preparedness . 2015;9:354–358)
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The global rise of Ebola viral diseases in 2014 necessitates legal responses that promote effective public health responses and respect for the health and human rights of populations. Compulsory public health interventions, approval and administration of experimental drugs or vaccines, and allocation of finite resources require difficult choices in law and policy. Crafting legal decisions in real-time emergencies is neither easy nor predictable, but it is essential to controlling epidemics and saving lives.(Disaster Med Public Health Preparedness. 2014;0:1-4).
Article
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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.
Conference Paper
Recognizing violations is a key issue in business process management (BPM). As a result that artifact-centric approach is becoming the development trend of BPM, we present a resolution for finding business violations through recognizing valid artifacts in business processes. We provide the formal definition of artifacts and artifact lifecycles, and, based on them, formulize the problem of recognizing valid artifacts. Previous methods for resolving this problem mainly put focus on activities in business process and lose the attention for data. In this work we concentrate on both the evolution of artifacts (data) and services (activities) applied on artifacts to identify the frontier between decidability and undecidability of the problem of recognizing valid artifacts. And we present the results of decidability under the conditions that artifact lifecycles are described in regular artifact lifecycle expressions and pushdown automata.
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Public health emergencies implicate difficult decisions among medical and emergency first responders about how to allocate essential resources. While various actors have proffered approaches on how to make these tough choices, meaningful guidance on shifting standards of care in major emergencies remained lacking. In March 2012, the Institute of Medicine (IOM) released additional guidance to assist facilities and practitioners to address scarce resource allocation through the development of "crisis standards of care" in catastrophes. As discussed in the article, identifying and resolving of complex practical, ethical, and legal challenges underlying real-time implementation of these standards are indispensable to protecting the public's health.
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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.
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Recent public health emergencies, such as the 2009 Influenza A/H1N1 Pandemic and Hurricane Katrina, underscore the importance of developing healthcare response plans and protocols for disasters impacting large populations. Significant research and scholarship, including the 2009 Institute of Medicine report on crisis standards of care and the 2008 Task Force for Mass Critical Care recommendations, provide guidance for healthcare responses to catastrophic emergencies. Most of these efforts recognize but do not focus on the unique needs of pediatric populations. In 2008, the Centers for Disease Control and Prevention supported the formation of a task force to address pediatric emergency mass critical care response issues, including legal issues. Liability is a significant concern for healthcare practitioners and facilities during pediatric emergency mass critical care that necessitates a shift to crisis standards of care. This article describes the legal considerations inherent in planning for and responding to catastrophic health emergencies and makes recommendations for pediatric emergency mass critical care legal preparedness. The Pediatric Emergency Mass Critical Care Task Force, composed of 36 experts from diverse public health, medical, and disaster response fields, convened in Atlanta, GA, on March 29-30, 2010, to review the pediatric emergency mass critical care recommendations developed by a 17-member steering committee. During the meeting, experts determined that the recommendations would be strengthened by a manuscript addressing legal issues. Authors drafted the manuscript through consensus-based study of peer-reviewed research, literature reviews, and expert opinion. The manuscript was reviewed by Pediatric Emergency Mass Critical Care Steering Committee members and additional legal counsel and revised. While the legal issues associated with providing pediatric emergency mass critical care are not unique within the overall context of disaster healthcare, the scope of the parens patriae power of states, informed consent principles, and security should be considered in pediatric emergency mass critical care planning and response efforts because parents and legal guardians may be unavailable to participate in healthcare decision making during disasters. In addition, practitioners who follow properly vetted and accepted pediatric emergency mass critical care disaster protocols in good faith should be protected from civil liability, and healthcare facilities that provide pediatric care should incorporate informed consent and security protocols into their disaster plans.
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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)
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This article applies developing concepts of mass critical care (MCC) to children. In public health emergencies (PHEs), MCC would improve population outcomes by providing lifesaving interventions while delaying less urgent care. If needs exceed resources despite MCC, then rationing would allocate interventions to those most likely to survive with care. Gaps between estimated needs and actual hospital resources are worse for children than adults. Clear identification of pediatric hospitals would facilitate distribution of children according to PHE needs, but all hospitals must prepare to treat some children. Keeping children with a family member and identifying unaccompanied children complicate PHE regional triage. Pediatric critical care experts would teach and supervise supplemental providers. Adapting nearly equivalent equipment compensates for shortages, but there is no substitute for age-appropriate resuscitation masks, IV/suction catheters, endotracheal/gastric/chest tubes. Limitations will be encountered using adult ventilators for infants. Temporary manual bag valve ventilation and development of shared ventilators may prolong survival until the arrival of ventilator stockpiles. To ration MCC to children most likely to survive, the Pediatric Index of Mortality 2 score meets the criteria for validated pediatric mortality predictions. Policymakers must define population outcome goals in regard to lives saved versus life-years saved.
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Serious outbreaks of avian influenza A (H5N1) have occurred among birds in Asia, with cases now reported in Europe.1 Although H5N1 is highly contagious among birds, it is rare in humans due to a significant species barrier.2 As of January 7, 2006, 146 cases were reported with 76 deaths.3 Human-to-human transmission has occurred, but transmission to date has not continued beyond one person.
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Highly pathogenic influenza A(H5N1) is endemic in avian populations in Southeast Asia, with serious outbreaks now in Africa, Europe, and the Middle East.1 Human cases, although rare, continue to increase, with high reported case-fatality rates. Industrialized countries place great emphasis on scientific solutions. The White House strategic plan and congressional appropriation both devote more than 90% of pandemic influenza spending to vaccines and antiviral medications.2 Yet, medical countermeasures, discussed in a previous JAMA Commentary, will not impede pandemic spread: experimental H5N1 vaccines may not be effective against a novel human subtype, neuraminidase inhibitors may become resistant, and medical countermeasures will be extremely scarce.3 This Commentary focuses on traditional public health interventions, drawing lessons from past influenza pandemics and the outbreaks of severe acute respiratory syndrome (SARS)4 (Table).
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The issues related to the funding for scientific research in Russia are discussed. Funding for scientific research was affected immediately after the collapse of the Soviet Union. It reduced from 3% of gross domestic product (GDP) to less than 1% of a much smaller GDP. Dmitri Kazakov, a theoretical particle physicist at the Joint Institute for Nuclear Research in Dubna, believes that the situation is beginning to get better. Most state funding of science in Russia still follows the top-down approach established in Soviet times. The institute themselves belong to the massive, bureaucratic Russian academy of Sciences (RAS), which employs over 100 000 scientists. Russian Foundation for Basic Research was established by the government that follows the Western model of giving money to individual groups on the basis of grant applications. It is hoped that some investment in science will come from Russia's newly made oil billionaires.
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Previous research suggests that "direct" reforms to the liability system-reforms designed to reduce the level of compensation to potential claimants-reduce medical expenditures without important consequences for patient health outcomes. We extend this research by identifying the mechanisms through which reforms affect the behavior of health care providers. Although we find that direct reforms improve medical productivity primarily by reducing malpractice claims rates and compensation conditional on a claim, our results suggest that other policies that reduce the time spent and the amount of conflict involved in defending against a claim can also reduce defensive practices substantially. In addition, we find that "malpractice pressure" has a more significant impact on diagnostic rather than therapeutic treatment decisions. Our results provide an empirical foundation for simulating the effects of untried malpractice reforms on health care expenditures and outcomes, based on their predicted effects on the malpractice pressure facing medical providers.
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Law influenced every aspect of the public health response to Hurricanes Katrina and Rita, from evacuation orders, to waivers of medical licensing requirements, to the clean-up of public health threats on private property. We used public health surveillance of news reports to identify and characterize legal issues arising during the disaster response in 5 Gulf Coast states. Data collected from news reports of the events in real time were followed-up by interviews with selected state legal and emergency management officials. Our analysis indicates the value of surveillance during and after emergency responses in identifying public health-related legal issues and helps to inform the strengthening of legal preparedness frameworks for future disasters.
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Dr. Anna Maria Pou was arrested following the deaths of four patients at Memorial Hospital after Hurricane Katrina hit. What precisely happened? And what lessons does the episode hold for health care workers, hospital administrators, and policymakers as they prepare for disasters? Dr. Susan Okie reports.
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