Healthcare-Related Disaster Legal/ Regulatory/ Federal Policy
Topic Collection
June 4, 2024
Topic Collection: Healthcare-Related Disaster Legal/ Regulatory/ Federal Policy
As the number of declared disasters increases, it is imperative that healthcare professionals are aware of state and federal emergency management resources and support, as well as the authorities under which response operations may be conducted. More specifically, it is critical that healthcare practitioners understand legislation and related programs that will allow them to respond during times of crisis knowing that certain liabilities have been waived, and much-needed human and material resources will be more readily available to them. The following resources highlight select laws, key issues, lessons learned, tools, and promising practices that can help healthcare professionals better understand the environment in which they will be asked to respond during large-scale emergencies.
NOTES: Many laws and regulations that have direct effects on healthcare operations during disasters are state and local (e.g., Good Samaritan, licensure/reciprocity, liability, emergency powers, health declarations, and county ordinances on EMS service provision) and are not addressed in detail in this Topic Collection. Additionally, because laws are continuously being updated and amended by legislative bodies, articles in legal journals can easily go out of date. This resource does not constitute legal advice, and readers should confer with their own legal counsel for legal advice that is up to date and applicable to their circumstances.
Additional resources that discuss laws, regulations, and legal considerations pertaining to public health/healthcare emergency response may be found in the following topic collections (listed alphabetically): Coalition Models and Functions; Coalition Response Operations (including Mutual Aid); Crisis Standards of Care; Ebola/VHF; Ethics; Influenza Epidemic/ Pandemic; Mass Distribution and Dispensing of Medical Countermeasures; Mental/Behavioral Health (non-responders); Pharmacy; Responder Safety and Health; Rural Disaster Health; Volunteer Management; and Zika.
Each resource in this Topic Collection is placed into one or more of the following categories (click on the category name to be taken directly to that set of resources). Resources marked with an asterisk (*) appear in more than one category.
Must Reads
The goal of the National Health Security Strategy (NHSS) is to strengthen and sustain communities’ abilities to prevent, protect against, mitigate the effects of, respond to, and recover from disasters and emergencies. This webpage includes links to the full text of the strategy, an overview, the NHSS Implementation Plan, the NHSS Evaluation of Progress, and an NHSS Archive.
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This document summarizes a selection of key federal legal authorities pertaining to public health emergencies.
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The National Response Framework is a guide to how the Nation responds to all types of disasters and emergencies. It is built on scalable, flexible, and adaptable concepts identified in the National Incident Management System to align key roles and responsibilities across the Nation. Emergency Support Function # 8, Public Health and Medical Services, is introduced and described.
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This webpage provides information on the Emergency Management Assistance Compact (EMAC), a congressionally-mandated interstate mutual aid agreement that has been adopted by all 50 states, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, and the Northern Mariana Islands. Under EMAC, state assets (supplies, equipment, and/or volunteers) may be deployed to a requesting state. Reimbursement, liability, compensation, and licensure issues are also addressed. The website has links to training and education resources, as well as a document library, and information on deployable resources. The “Learn about EMAC” menu provides helpful documents for those not familiar with the agreement and process.
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The authors provide an overview of the "basic legal framework for states to accomplish interstate and international mutual aid, identify gaps in that framework, and suggest steps that could be taken to address those gaps." The need for mutual aid for smaller-scale incidents that fall outside the scope of the Emergency Management Assistance Compact is highlighted. Summaries of relevant authorities are included.
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This collection includes links to resources on a variety of health law topics, including social distancing powers, liability, mental and behavioral health preparedness, and crisis standards of care. Emergency planners and public health officials can use these resources when developing plans and/or responding to local, state, or regional public health emergencies.
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This document provides answers to frequently asked questions about healthcare delivery after natural and human-caused disasters.
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This guidance can help users determine how the HIPAA Privacy Rule applies to the information in question. Users can go to the question that relates most closely to their inquiry and follow the flow of information to locate a response.
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When the U.S. Department of Health and Human Services (HHS) Secretary declares a public health emergency under Section 319 of the Public Health Service Act, s/he may temporarily waive or modify certain requirements to ensure that there are enough health care resources and services available to meet the needs of the public’s health. A presidential declaration of emergency under the National Emergencies Act or Stafford Act is also required for Section 1135 waivers. This document highlights examples of waivers and other related information.
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This webpage includes questions and answers regarding the discretionary actions the Secretary of Health and Human Services may take in response to a public health emergency.
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This document explains the U.S. Food and Drug Commissioner's authority to issue an Emergency Use Authorization (EUA) for unapproved medical products or unapproved uses of approved medical products during emergencies caused by CBRN threat agents when approved products/uses do not exist. There is also a list of current EUAs, and a link to Frequently Asked Questions about EUAs.
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Disaster Legal/Regulatory Considerations for Healthcare Systems
Interviews with public health and emergency management officials noted distinctly different perceptions about public health law which could adversely affect inter-agency collaboration. Clarification for both entities on legal authorities, scope, and ethical concerns related to both federal and state laws is recommended to advance joint emergency preparedness.
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Using the Preston v Tenet Healthsystem Memorial Medical Center case as a backdrop, the authors discuss considerations related to the assessment of liability for healthcare entities that do not adequately prepare for large-scale emergencies.
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Legal advancements since 2001 are discussed in their role to improve response in public health emergencies in an effort to decrease morbidity and mortality. However issues remain to resolve coordination among agencies, promote timely legal decision making including declarations of an emergency, disaster or public health emergency and liability protection for emergency responders.
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The legal requirements for hospital emergency preparedness during disaster declarations are discussed in terms of issues that may be encountered. The risk and liability associated with a failure to plan and prepare and to be capable of real-time decision-making are detailed including negligence, discrimination and criminal culpability during and after medical triage.
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The authors assessed real-time decision-making processes among legal and public health professionals during a fictitious public health emergency scenario and found that the perception of relevance of legal preparedness impacted decision-making. Lessons learned are shared for integration in future exercises or real public health emergencies.
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The authors discuss law and policy issues anticipated to arise during implementation of crisis standards of care. Table 1 lists select related legal issues by subject (e.g., organization of personnel, patients' interests, allocation of resources, and reimbursement).
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The article reviews the “top 10” key areas of law and policy to prepare attorneys to provide “competent” guidance on the legal aspects of public health control and mitigation during emergencies.
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Liability exposure issues in public health emergencies are presented that can affect the spectrum of the healthcare delivery system with insufficient qualified staff, resource issues and an overwhelming patient surge. Immunity sources are discussed for public and private sector responders, including volunteers.
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The results of a study of 144 interviews in nine states noted gaps in how local public health and emergency management professionals perceived legal requirements. The authors note that training in legal preparedness and being able to receive timely clarification to resolve issues could improve morbidity and mortality outcomes during a public health emergency.
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The authors reviewed judicial opinions related to disasters that occurred in the United States between September 11, 2001, and December 31, 2015. The most prevalent emergency response activities at issue were disaster mitigation (29.3%), disaster clean-up (21.9%), a defendant’s duty to plan (14.4%), evacuation (12.6%), and conditions of incarceration (12.1%). They found that medical services or triage during an emergency are discussed in only 7 cases (3.3%) out of the 215 they included, but note that “this does not imply that litigation arising from health care provided during an emergency is not an area of concern.”
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Education and Training
These three 40-minute units (introduction to emergency management systems preparedness and response; emergency powers specific to personnel; and emergency powers specific to property and supplies) can help planners make informed legal decisions before, during, and after public health emergencies.
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The academy offers links to free, self-paced, online training that can help state, tribal, local, and territorial public health and healthcare professionals a better understanding of "the use of law and policy for improving population health outcomes."
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This hour-long webinar discusses who has to follow Health Insurance Portability and Accountability Act (HIPAA) regulations, disclosures for public health activities during an emergency, additional disclosures during emergencies, and the minimum necessary rule.
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This hour-long webinar and its accompanying 124-page report feature research and analysis of legal issues impacting emergency medical Services (EMS) providers and others during medical surge. Topics include: identifying emergency, disaster, or public health emergency authorities; use of protocols to authorize specific actions among EMS providers; licensing reciprocity for EMS providers; modifying scopes of practice for emergency medical technicians and paramedics; state equivalents or extensions of requirements pursuant to the Emergency Medical Treatment and Labor Act concerning screening and treatment at non-hospital sites; and legal accountability for EMS providers.
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The Public Health Law 101 course provides an introduction to fundamental principles of law, ethics, and the legal system as they frame public health practice in the United States. It is meant to be delivered by attorneys. Module 6 content includes a review of the basic principles of health information privacy, confidentiality, and security, as well as the scope, structure, and implementation of the HIPAA privacy rule.
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Hodge, J.G. (2013).
Public Health Law in a Nutshell: Chapter 10-Public Health Legal Preparedness and Response.
(Book available for purchase.) West Academic Publishing.
This brief chapter provides a concise and clear assessment of the legal environment in declared emergencies involving the public’s health. It is a key starting point for anyone attempting to assess federal, state, and local legal provisions and responsibilities in major crisis events.
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This is a customizable training kit to help local jurisdictions prepare their public health staff and legal counsels to better understand the legal environment in which they must plan for, respond to, and recover from emergencies. The kit consists of a PowerPoint presentation; an Instruction Manual; component summaries updated in 2012; and a sample packet of modifications made by Florida State University in September 2013. There is also a 53-minute video to guide users of the training kit.
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This two-hour, 39-minute video presents a panel discussion at Georgetown Law School by public health preparedness leaders, officials, and experts, who discuss issues that are important to disaster and preparedness law. They examine critical challenges in emergency legal preparedness and policy, including federal social distancing powers, emergency use authorizations, strategic national stockpile (SNS) distributions, emergency vaccine development and access, and federal-state implications for the next emerging threat. (Note that the program starts at around minute 22.)
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In this 28-minute podcast, the speakers discuss the importance of enhancing legal preparedness capacity before disasters, with a focus on sovereign tribal nations and the differences in tribal vs. state laws and relation to federal laws.
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An infectious disease scenario that combined training with a tabletop exercise was analyzed as effective in advancing knowledge about legal authorities, policies and procedures and assisted in identification of local gaps that could impact confidence in operationalizing isolation and quarantine measures, restriction in public movement and public spaces, and mass prophylaxis. Participants were more aware that legal authorities existed than policies and procedures associated with how to implement them.
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This 1.5-hour course (while dated) provides a general overview of public health law in emergency preparedness. Legal questions relating to the use of medical or public health volunteers during emergencies are addressed.
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Event-Specific Lessons Learned
This webpage includes information on, and links to, waivers issued by the Centers for Medicare & Medicaid Services (CMS) following hurricanes and tropical storms over the last few years. This information may be helpful to planners in understanding how requirements may change following a declared public health emergency to allow healthcare facilities to provide necessary care to those affected by the disaster. Information on waivers issued for other emergencies may be found on the CMS website, under “Current Emergencies,” or “Past Emergencies.”
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The authors describe the State of New Jersey’s activation of the Emergency Management Assistance Compact (EMAC) in response to Superstorm Sandy. Each EMAC phase is described, and the authors share best practices that can be used by emergency healthcare providers and planners.
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The authors reviewed litigation related to public health measures enacted during the COVID-19 pandemic and found that courts primarily assess these claims under two approaches: weighing the "application of rights against governments’ compelling interests to protect public health and safety in emergencies" and setting "aside existing rights to effectuate emergency responses." The authors believe neither approach suffices and suggest that courts focus on "public health interventions as a constitutional prerogative instead of examining alleged rights infringements framed outside crisis contexts."
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The authors share guidance on topics at the intersection of law, medicine, and preparedness for managing Ebola, including the willingness among health workers and entities to handle known or suspect cases; use of novel treatments and experimental drugs; isolation, quarantine, and other social-distancing measures in medical settings; and prospective liabilities of health workers or entities for medical errors or omissions in the handling or treatment of Ebola cases.
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The authors systematically identified and analyzed state emergency preparedness laws that could have affected evacuation of and sheltering-in-place in hospitals in order to characterize the public health legal preparedness of 4 states (Delaware, Maryland, New Jersey, and New York) in the mid-Atlantic region during Hurricane Sandy in 2012. They conclude that states would be better prepared for future emergencies if they ensure explicit statutory authority to order evacuation and to order sheltering-in-place, particularly of hospitals, where it does not currently exist.
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This document provides a snapshot of Hurricanes Harvey, Irma, and Maria and a timeline on the state and federal emergency declarations declared in response to these hurricanes. Topics include: Impacts of Hurricanes Harvey, Irma, and Maria; Federal Declared Emergencies; State Declared Emergencies; Emergency Legal Preparedness Issues; and Recommended Resources.
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This document highlights language that supports the adherence to civil rights laws and disability rights laws in the application of Crisis Standards of Care during resource-constrained emergencies, such as the COVID-19 pandemic.
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This document discusses waivers issued by the Secretary of Health and Human Services following Hurricane Harvey in 2017 of the sanctions and penalties against a covered hospital that does not comply with provisions of the HIPAA Privacy Rule. This information may be helpful to planners in understanding how requirements may change following a declared public health emergency to allow healthcare facilities to provide necessary care to those affected by the disaster.
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Federal and State Authorities/Legislation
This webpage includes links to the text of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. This law: authorizes a funding increase for the Hospital Preparedness Program; directs ASPR, the Director of National Intelligence, and the Department of Homeland Security to coordinate regularly on threat assessments; allows states to request temporarily deployment of state personnel whose salaries are funded by HHS in whole or in part under Public Health Service Act programs; authorizes coalitions to use funds for response activities; authorizes ASPR to establish guidelines for the Regional Disaster Health Response System; allows programs to develop medical countermeasures for pandemic influenza and other emerging infectious diseases to receive annual funding from Congress; and authorized appropriations for Project BioShield for 10 years, among other provisions. (Access the 2006 Act here: https://www.congress.gov/bill/109th-congress/senate-bill/3678/text/pl; access the 2013 reauthorization here: http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf).
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Knowing what kinds of patient information can be released, to whom, and under what circumstances, is critical for healthcare facilities in disaster response. This guide is designed to answer frequently asked questions regarding the release of information about patients following an incident.
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This fact sheet addresses several frequently asked questions regarding the Emergency Medical
Treatment and Labor Act (EMTALA) and disasters and provides links to resources for more
information, but is not intended to be used as regulatory guidance or in place of
communications with or guidance from the Centers for Medicare & Medicaid Services (CMS)
which oversee EMTALA compliance.
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The Centers for Medicare & Medicaid Services issued the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers Final Rule to establish consistency for healthcare providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and human-caused disasters. This document provides links to numerous related resources applicable to a variety of providers and suppliers.
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This toolkit contains a review of key emergency authority and immunity concepts; a summary of federal laws and policies pertaining to emergency planning and response; and a series of fact sheets addressing fundamental issues or legal authorities, issue briefs, and state analysis guides.
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This document summarizes a selection of key federal legal authorities pertaining to public health emergencies.
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This webpage from the Centers for Medicare &Medicaid Services and Children's Health Insurance Program (CHIP) includes links to tools that summarize the types of Medicaid and CHIP strategies states and territories can deploy during disasters, and a companion inventory documenting the legal authorities and the action needed to effectuate these strategies.
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A summary sheet provides responses to questions of payment, conditions of participation and standards of care associated with hospital alternative care sites established to support the H1N1 patient medical surge. It includes a discussion of EMTALA issues and Social Security Act section 1135 waiver compliance alternatives to hospitals.
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This webpage provides an overview of the Emergency Preparedness Rule and links to related resources. The website materials reflect current guidance including 2019 updates.
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This memorandum and associated fact sheet (from 2009) describes EMTALA requirements and flexibility for an appropriate Medical Screening Examination and options for hospitals experiencing an exceptional patient surge. Alternate screening sites on a hospital’s campus, referral to a hospital-controlled off-campus site, and referral to a community screening site are addressed in terms of an EMTALA obligation.
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The authors describe the State of New Jersey’s activation of the Emergency Management Assistance Compact (EMAC) in response to Superstorm Sandy. Each EMAC phase is described, and the authors share best practices that can be used by emergency healthcare providers and planners.
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This report provides information to aid policymakers as they navigate the levels of responsibility of the national emergency management structure, and numerous policy pressure points. It describes the laws and administrative policies governing the disaster response and recovery process. It also reviews the legislative framework that exists for providing federal financial assistance following disasters, as well as the policies the executive branch employs to provide supplemental help to state, tribal, and local governments during times of disasters.
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The authors discuss federal legal tools that are critical to enhancing medical countermeasure legal preparedness for public health emergencies. They focus on the Public Readiness and Emergency Preparedness (PREP) Act and Emergency Use Authorization (EUA) authority to facilitate the emergency use of countermeasures.
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This article explains the Federal Tort Claims Act (FTCA), which allows the government to be sued and assume the liability of its employees for negligence occurring as part of their normal duties. Volunteers deployed by federal agencies are covered by the FTCA.
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This bench book provides Florida judges with information they need for when they are presented with public health cases. The document begins with an introduction of public health law in the context of a public health emergency, executive powers in a public health emergency, and Florida Executive Branch procedures in an emergency. It then goes into the role of Florida Courts, and other legal issues for the Courts to consider during a public health emergency. It also provides guidance for maintaining essential court functions during a pandemic.
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This Act revised a number of provisions in the Stafford Act and the Homeland Security Act to strengthen the nation’s response to disasters and emergencies.
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This article reviews the HIPAA rules on contingency planning and outlines key steps for healthcare organizations to take to achieve compliance with the requirements.
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The author reviews laws related to liability and immunity and provides a proposal to address gaps in the legislation. Specifically, she advocates for paid health care professionals who must care for patients during disasters as part of their jobs to be afforded the same protections extended to volunteers.
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The authors examine the role of the Federal Tort Claims Act (FTCA), which provides legal liability coverage for federal government employees, in aiding the emergency deployment of first-responder health-care workers employed by federally qualified health centers. An overview of the FTCA, as well as a discussion of a federal ruling's public health policy and practice implications for communities nationwide, are included.
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The evolution of authorities and public health liability protection for emergency use of medical countermeasures, associated with the Pandemic and All-Hazards Preparedness Reauthorization Act, is analyzed to advance emergency preparedness and response activities and protection of personnel.
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This webpage includes a table that summarizes state law authority for quarantine and isolation within state borders, including authority to initiate quarantine and isolation, limitations on state quarantine powers, and penalties for violations.
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This webpage provides information on the Emergency Management Assistance Compact (EMAC), a congressionally-mandated interstate mutual aid agreement that has been adopted by all 50 states, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, and the Northern Mariana Islands. Under EMAC, state assets (supplies, equipment, and/or volunteers) may be deployed to a requesting state. Reimbursement, liability, compensation, and licensure issues are also addressed. The website has links to training and education resources, as well as a document library, and information on deployable resources. The “Learn about EMAC” menu provides helpful documents for those not familiar with the agreement and process.
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This document discusses liability protections that have been put in place at both the state and local levels for different types of actors and entities involved in emergency response efforts. It includes a two-page table that highlights these potential liability protections for individuals, including healthcare workers, volunteers, and private sector employees; and entities, including government agencies, hospitals or healthcare facilities, non-profit organizations, and for-profit organizations.
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This article outlines the Health and Human Services Secretary's public health emergency (PHE) authority, discusses possible discretionary actions that the secretary may take after declaring a PHE, and provides examples of PHE declarations that have been issued.
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Although the focus of the article is nuclear events, it provides a general overview of legal authorities relevant to emergencies.
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This article discusses the steps that the Department of Health and Human Services follows to authorize emergency use of products under section 564 of the Federal Food, Drug and Cosmetic Act through Emergency Use Authorizations.
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The authors provide an overview of the "basic legal framework for states to accomplish interstate and international mutual aid, identify gaps in that framework, and suggest steps that could be taken to address those gaps." The need for mutual aid for smaller-scale incidents that fall outside the scope of the Emergency Management Assistance Compact is highlighted. Summaries of relevant authorities are included.
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This directive establishes the National Incident Management System (NIMS) to ensure a comprehensive and unified approach to crisis and consequence management across all levels of government in the United States.
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This directive establishes a National Strategy for Public Health and Medical Preparedness. It requires planning for a rapid and coordinated public health and medical response during large-scale disasters.
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U.S. Congress. (n.d.).
Section 1812.
(Accessed 1/16/2020.) Social Security Administration.
This section of the Social Security Act discusses coverage of skilled nursing facility (SNF) and hospice care for beneficiaries. Following the 2017 hurricanes, waivers of Section 1812 (f) were issued by the Centers for Medicare & Medicaid Services (CMS), which allowed Medicare to pay for SNF services without a 3-day qualifying stay at an inpatient hospital, and cover SNF care without requiring a break in the spell of illness for affected individuals who had already used up their SNF days.
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This is the text of Section 1135 of the Social Security Act, which allows the Secretary of Health and Human Services (HHS) to temporarily waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) requirements affecting healthcare facilities and providers during declared public health emergencies when the President has also declared an emergency or major disaster under the Stafford Act or National Emergencies Act.
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The National Emergencies Act (NEA) allows the president to declare a national emergency and provides a framework for exercising.
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This is the original text of the Public Readiness and Emergency Preparedness (PREP) Act, which allows the Secretary of Health and Human Services (HHS) to issue a declaration providing immunity from state and federal liability to persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures, and provides a compensation program to certain individuals who receive covered countermeasures. A PREP Act declaration may be declared even if a public health emergency is not. The PREP Act, as codified as sections 319F-3 and 319F-4 of the PHS Act, 42 U.S.C. 247d-6d and 247d-6e, was amended in 2013 by PAHPRA.
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This link to the electronic code of federal regulations includes those for federal emergency management and assistance by the Federal Emergency Management Agency (FEMA) after disasters.
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The Stafford Act establishes the statutory authority for most federal disaster response activities and assistance to state, local, and tribal governments. In particular, the Stafford Act creates the system for federal financial and physical assistance during a presidential emergency or major disaster declaration.
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The Privacy Rule protects patient information from being shared by covered entities (including health care providers) other than to provide treatment and care, allow for billing and payment, protect the public’s health, or report required information to police. As part of a declaration of a public health emergency under section 319 of the Public Health Service Act, penalties for violating the Privacy Rule may be waived.
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This document discusses waivers issued by the Secretary of Health and Human Services following Hurricane Harvey in 2017 of the sanctions and penalties against a covered hospital that does not comply with provisions of the HIPAA Privacy Rule. This information may be helpful to planners in understanding how requirements may change following a declared public health emergency to allow healthcare facilities to provide necessary care to those affected by the disaster.
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The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response (ASPR), comprising the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and interagency partners at the Departments of Veterans Affairs (VA), Defense (DoD), Homeland Security (DHS), and Agriculture (USDA). It coordinates the development, acquisition, stockpiling, and use of medical products that are needed to effectively respond to a variety of potential high consequence public health emergencies, whether naturally occurring or intentional. This plan describes PHEMCE's priorities for the next five years.
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This guidance can help users determine how the HIPAA Privacy Rule applies to the information in question. Users can go to the question that relates most closely to their inquiry and follow the flow of information to locate a response.
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U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response. (n.d.).
PREP Act Questions and Answers.
(Accessed 3/12/2024.)
This webpage includes questions and answers intended for the manufacturing industry, the healthcare community, and state and local government officials about the PREP Act. It does not represent an exhaustive review of the PREP Act’s provisions in all contexts or a protocol for the implementation of the PREP Act.
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Resources on this federal webpage describe the Privacy Rule (also referred to as HIPAA) and address the release of protected health information for planning or response activities in emergency situations. Links to bulletins from recent incidents are included
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This webpage includes questions and answers regarding the discretionary actions the Secretary of Health and Human Services may take in response to a public health emergency.
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The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response summarizes legal authorities of the Secretary to respond to public health emergencies under the Public Health Service Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) and the Pandemic and All-Hazards Preparedness Reauthorization (PAHPRA) Act and provides links to related legal authorities and frequently asked questions.
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U.S. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response. (2016).
1135 Waivers.
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In 2011, President Obama directed the development of a national preparedness goal that stressed security and resilience through preparation for natural and human-caused events.
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The FDA works within this framework to ensure that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats. This webpage includes links to related legislation, emergency use authorities of the FDA, and legal and policy presentations, publications, and other information.
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This document explains the U.S. Food and Drug Commissioner's authority to issue an Emergency Use Authorization (EUA) for unapproved medical products or unapproved uses of approved medical products during emergencies caused by CBRN threat agents when approved products/uses do not exist. There is also a list of current EUAs, and a link to Frequently Asked Questions about EUAs.
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Guidance/Guidelines
This Policy Statement was created “to educate and raise awareness for providers and policy makers about the current state of liability risk and protection for health care providers who are caring for children during disasters.” Recommendations are included for pediatricians, the US Department of Health and Human Services, healthcare entities, and medical liability insurers. https://pediatrics.aappublications.org/content/early/2019/02/21/peds.2018-3892
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This article details legal suggestions made by the American College of Chest Physicians (CHEST) Task Force for Mass Critical Care geared towards front-line clinicians, hospital administrators, and public health or government officials involved in treating patients during a pandemic or disaster with multiple critically ill or injured patients.
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This report was designed to help authorities operationalize the concepts first developed in the 2009 Institute of Medicine (now known as the National Academy of Medicine) document titled, “Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report.” Volume 1, Section 3 provides an overview of legal and liability issues in catastrophic disasters. Legal and regulatory issues are a frequently discussed point in other areas of the document as well.
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This review summarizes legal and policy issues associated with distributing and dispensing antivirals and explores solutions to these issues. It also includes examples of existing applicable state statutory and regulatory provisions.
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This resource contains four sets of standalone tools: the Emergency Declaration Toolset; Emergency Procurement Toolset; Expedited Staffing Toolset; and the Mutual Aid Agreement and Memorandum of Understanding Toolset. The guidebook was designed to help public health professionals with their preparedness capabilities and encourage collaboration among all stakeholders involved in disaster preparedness and response.
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This document provides a menu of provisions for inclusion in a mutual aid agreement in support of public health emergency response. Although targeted to government planners and their legal counsels, the guidance in the document may be helpful to health care facilities as a reference for developing mutual aid agreements with other facilities to share information, data, supplies, resources, equipment, or personnel during emergencies and disasters.
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This document provides answers to frequently asked questions about healthcare delivery after natural and human-caused disasters.
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When the U.S. Department of Health and Human Services (HHS) Secretary declares a public health emergency under Section 319 of the Public Health Service Act, s/he may temporarily waive or modify certain requirements to ensure that there are enough health care resources and services available to meet the needs of the public’s health. A presidential declaration of emergency under the National Emergencies Act or Stafford Act is also required for Section 1135 waivers. This document highlights examples of waivers and other related information.
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Plans, Tools, and Templates
Memoranda of Understanding are considered one of the most common cooperative arrangements for healthcare facilities in disasters. This model template can be used by those facilities looking for a way to address resource sharing with neighboring facilities as part of their EOP.
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This webpage includes a series of toolkits “that address the key information needs of public health officials in understanding and using legal authorities to prepare for and respond to public health emergencies.” Topics include: Scope of Practice; Emergency Volunteers; and Emergency Use Authorizations.
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This document provides the background and text for a model Memorandum of Understanding (MOU) between hospitals during declared emergencies. The model MOU was developed by the National Center for the Study of Preparedness and Catastrophic Event Response (PACER) at Johns Hopkins University.
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This toolkit provides guidance to state health agencies to engage pharmacies in supporting the response to influenza pandemics and other vaccine-related public health emergencies. It describes steps to take and templates to use in developing an MOU between public health agencies and pharmacies.
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This collection includes links to resources on a variety of health law topics, including social distancing powers, liability, mental and behavioral health preparedness, and crisis standards of care. Emergency planners and public health officials can use these resources when developing plans and/or responding to local, state, or regional public health emergencies.
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Response Roles, Responsibilities, and Plans
The goal of the National Health Security Strategy (NHSS) is to strengthen and sustain communities’ abilities to prevent, protect against, mitigate the effects of, respond to, and recover from disasters and emergencies. This webpage includes links to the full text of the strategy, an overview, the NHSS Implementation Plan, the NHSS Evaluation of Progress, and an NHSS Archive.
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This publication describes the roles of the Armed Forces of the United States in defense support of civil authorities during disasters including key differences between National Guard and active duty elements as well as the roles that they can fulfill. Chapter II focuses on "supporting a comprehensive all hazards response."
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The National Response Framework is a guide to how the Nation responds to all types of disasters and emergencies. It is built on scalable, flexible, and adaptable concepts identified in the National Incident Management System to align key roles and responsibilities across the Nation. Emergency Support Function # 8, Public Health and Medical Services, is introduced and described.
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Federal Interagency Operational Plans (FIOPs) describe the concept of operations for integrating and synchronizing existing national-level Federal capabilities to support local, state, tribal, territorial, insular area, and Federal plan. There is one FIOP for each mission area: prevention; protection; mitigation; response; and recovery.
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The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response (ASPR), comprising the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and interagency partners at the Departments of Veterans Affairs (VA), Defense (DoD), Homeland Security (DHS), and Agriculture (USDA). It coordinates the development, acquisition, stockpiling, and use of medical products that are needed to effectively respond to a variety of potential high consequence public health emergencies, whether naturally occurring or intentional. This plan describes PHEMCE's priorities for the next five years.
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Volunteer / Provider Liability and Legal Issues
This webpage describes the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP) program, which provides standards and guidelines to assist states with setting up standardized volunteer databases to support public health and medical response during disasters. ESAR-VHP registries allow volunteers' identities, licenses, credentials, accreditations, and hospital privileges to be verified in advance of an emergency, facilitating more rapid deployment.
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This webpage provides information on which states have adopted the Uniform Emergency Volunteer Health Practitioners Act (UEVHPA), and which states have introduced legislation to do so. Links to the UEVHPA, a legislative information kit, and other resources are also available.
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The authors discuss key issues of emergency laws among select U.S. localities in the context of the 2009 H1N1 outbreak and their application to volunteer health professionals. They maintain that differences in local laws add additional complexity to legal preparedness and necessitate more pre-disaster planning, exercises, and coordination.
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This conference paper summarizes concepts and issues pertinent to emergency volunteers. It also includes an overview of state and federal laws that provide liability coverage and/or immunity to volunteers, and notes when such protections would apply.
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This report provides an overview of the federal and state liability protections available to volunteer health professionals.
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Disaster responders can use the information on this webpage to stay abreast of the legal landscape in the jurisdictions they serve. Users can filter results by topics such as liability, licensure, scope of practice, and workers’ benefits to find applicable laws.
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This document provides guidance on legal considerations (particularly liability) for emergency volunteer programs.
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This article describes the development of The Uniform Emergency Volunteer Health Practitioners Act, which allows state governments during a declared emergency to give reciprocity to other states’ licensees on emergency services providers so that covered individuals may provide services without meeting the disaster state’s licensing requirements.
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This document discusses liability protections that have been put in place at both the state and local levels for different types of actors and entities involved in emergency response efforts. It includes a two-page table that highlights these potential liability protections for individuals, including healthcare workers, volunteers, and private sector employees; and entities, including government agencies, hospitals or healthcare facilities, non-profit organizations, and for-profit organizations.
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The author contends that granting immunity to volunteer health professionals during public health emergencies is unnecessary and that such laws "discriminate against poor people" and could "undermine" response efforts. Several alternative approaches are presented, such as creating compensation pools for victims of gross negligence and having the federal government indemnify emergency response volunteers instead of granting them immunity.
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This is the text of the Volunteer Protection Act, which provides volunteers of nonprofit organizations or governmental entities some liability protections for economic damages resulting from activities relating to the work of the organizations. It does not cover gross negligence, willful misconduct, recklessness, or acts committed by the volunteer while intoxicated or operating a motor vehicle. Volunteers must be licensed or certified, as required to fulfill their assigned duties. Civil actions against volunteers by the organization they work for are not precluded. It does not cover organizational entities of any type, or persons volunteering at private businesses. A declared emergency is not necessary for volunteers to receive protections under this Act. States may opt out of the Volunteer Protection Act.
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U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response. (2021).
Medical Reserve Corps.
This webpage describes the Medical Reserve Corps (MRC) program and provides links to the 854 local units across the U.S. and its territories. The MRC is a national network of local volunteer units created to strengthen their community's health, improve its emergency response capabilities, and build its resiliency.
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Agencies and Organizations
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