The Need for Historical Fluency in Pandemic Law and Policy.

The primary claim of this essay is that historical fluency is required for effective work in crafting legal and policy interventions as a part of public health emergency preparedness and response (PHEPR). At a broad level, public health law is explicitly recognized as a key systems-level component of PHEPR practice.1 This essay therefore focuses on the extent to which historical fluency is necessary or at least useful to all aspects of PHEPR that draw on or deploy legal and policy mechanisms (e.g., design, planning, implementation, dissemination, monitoring and evaluation, etc.). The essay collectively refers to these legal and policy mechanisms as epidemic law and policy response (ELAPR). Part I explains the concept of historical fluency. Part II explores the foundations of public health law both as a way of highlighting key structural features of ELAPR and in supporting the claim that historical fluency is critical for ELAPR. Part III applies the previous arguments to a specific case study to highlight the promise and power of historical fluency - the outbreak of bubonic plague in San Francisco in 1900. Tracking this essay's pragmatic focus, part IV offers several recommendations for how specifically historical fluency in public health law and ethics can be operationalized in PHEPR practice and policy. Part V summarizes and concludes.

Funding Public Health Emergency Preparedness in the United States.

The historical precedents that support state and local leadership in preparedness for and response to disasters are in many ways at odds with the technical demands of preparedness and response for incidents affecting public health. New and revised laws and regulations, executive orders, policies, strategies, and plans developed in response to biological threats since 2001 address the role of the federal government in the response to public health emergencies. However, financial mechanisms for disaster response-especially those that wait for gubernatorial request before federal assistance can be provided-do not align with the need to prevent the spread of infectious agents or efficiently reduce the impact on public health. We review key US policies and funding mechanisms relevant to public health emergencies and clarify how policies, regulations, and resources affect coordinated responses.

The new CMS emergency preparedness final rule and its impact on healthcare in 2017.

The new CMS Final Rule on Emer- gency Preparedness will be a major change for hospitals and many other types of healthcare providers, the authors claim. One of the most im- portant changes for hospitals will be the requirement to do the Security Risk Assessments and matching Emergency Plans for each separate facility, every year, instead of only doing a consolidated risk assess- ment on all facilities in one report. Failure to comply could have a major and disastrous economic im- pact on a hospital or other health care facility. In this article they pro- vide information and access to re- sources for complying.

Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. Final rule.

This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.

Health Resources Priority and Allocations System (HRPAS). Interim final rule.

This interim final rule establishes standards and procedures by which the U.S. Department of Health and Human Services (HHS) may require that certain contracts or orders that promote the national defense be given priority over other contracts or orders. This rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule will implement HHS's administration of priorities and allocations actions, and establish the Health Resources Priorities and Allocation System (HRPAS). The HRPAS will cover health resources pursuant to the authority under Section 101(c) of the Defense Production Act as delegated to HHS by Executive Order 13603. Priorities authorities (and other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation) may be re-delegated by the Secretary. The Secretary retains the authority for allocations.

[Code of civil procedure for medical workers--evidence of fact finding and efficacy of judgment].

For a fair trial, fact finding shall certainly be based on evidence, and examination of evidence is performed using means, such as documentary evidence, validity, examination, and expert opinion. In fact finding, in order to eliminate a judge's arbitrariness and to secure justice, we have to make the process of fact finding rational and objective. For this reason, the court must recognize the fact used as the foundation of judgment based on the presented proof on the basis of participation of both parties concerned. As an effect of the judgment, there ensure res judicata and power of execution. They serve as a binding force to a next trial.

Evaluation of Brazil's public health surveillance system within the context of the International Health Regulations (2005).

OBJECTIVE: To evaluate Brazil's public health surveillance system (HSS), identifying its core capacities, shortcomings, and limitations in dealing with public health emergencies, within the context of the International Health Regulations (IHR 2005). METHODS: In 2008-2009 an evaluative cross-sectional study was conducted using semistructured questionnaires administered to key informants (municipal, state, and national government officials) to assess Brazilian HSS structure (legal framework and resources) and surveillance and response procedures vis-à-vis compliance with the IHR (2005) requirements for management of public health emergencies of national and international concern. Evaluation criteria included the capacity to detect, assess, notify, investigate, intervene, and communicate. Responses were analyzed separately by level of government (municipal health departments, state health departments, and national Ministry of Health). RESULTS: Overall, at all three levels of government, Brazil's HSS has a well-established legal framework (including the essential technical regulations) and the infrastructure, supplies, materials, and mechanisms required for liaison and coordination. However, there are still some weaknesses at the state level, especially in land border areas and small towns. Professionals in the field need to be more familiar with the IHR 2005 Annex 2 decision tool (designed to increase sensitivity and consistency in the notification process). At the state and municipal level, the capacity to detect, assess, and notify is better than the capacity to investigate, intervene, and communicate. Surveillance activities are conducted 24 hours a day, 7 days a week in 40.7% of states and 35.5% of municipalities. There are shortcomings in organizational activities and methods, and in the process of hiring and training personnel. CONCLUSIONS: In general, the core capacities of Brazil's HSS are well established and fulfill most of the requisites listed in the IHR 2005 with respect to both structure and surveillance and response procedures, particularly at the national and state levels.

Preparedness for radiological emergency situations in Austria.

This article presents the Austrian system of emergency preparedness for nuclear and radiological emergency situations. It demonstrates, in particular, the legal basis, the roles and competencies of the competent authorities, international and bilateral conventions on early notification of nuclear accidents, the Austrian emergency plans, the Austrian radiation monitoring system, the operated prognosis and decision support systems and the results of an estimation of possible impacts of nuclear power plant disasters on Austria.

Setting up an off-site emergency mortuary facility (EMF) to deal with a DVI incident: disaster victim management (DVM).

Forensic mortuaries in all Australian jurisdictions are dealing with increasing workloads, with routine cases regularly occupying greater than 50%, and often as much as 85%, of existing cold room body storage capacity, particularly over long weekends and during seasonal increases in respiratory infections. Hence the need to deal with a sudden influx of deceased persons or multiple body parts in a mass fatality incident would overwhelm most Australian forensic mortuaries, thereby requiring other means of body storage and processing. Exercise "Construct" was a joint South Australian Police (SAPol) and Forensic Science South Australia exercise designed to practice the establishment and construction of an emergency mortuary facility (EMF) to deal with a mass fatality incident and the subsequent disaster victim identification process. The aims of the exercise were to test preparedness, activation and construction processes relative to the establishment of an EMF. The exercise provided the opportunity to identify gaps in the capacity to successfully complete the tasks within the allotted time frames. The exercise reinforced the need to have a comprehensive and clearly documented process which must include a current list of suppliers who can deliver goods and services in a timely manner. The aim of this paper is to report on the exercise findings and share the experience with other jurisdictions. It will also provide other jurisdictions with the opportunity to consider whether the South Australian model will be useful to them in improving their own response when confronted with a mass fatality incident that may overwhelm existing local mortuary capacities and capabilities.

[Medical accidents and defense activities against criminal investigation--the attorney's point of view].

Even after the criminal investigation has begun on a medical accident, immediate defense activities can prevent false indictment. On appointing a lawyer, one has to be careful of "conflicts of interests". Defense lawyers try to reconstruct what happened on the scene with the records and the comments of the persons involved. Meanwhile, they try to nail down the medical standards in the particular case by scrutinizing medical bibliography. If they succeed in pointing out to the authorities the possibilities of not guilty verdict, arrest or indictment can be avoided.

Achieving public health legal preparedness: how dissonant views on public health law threaten emergency preparedness and response.

BACKGROUND: Effective management of modern public health emergencies requires the coordinated efforts of multiple agencies representing various disciplines. Organizational culture differences between public health (PH) and emergency management (EM) entities may hinder inter-agency collaboration. We examine how PH and EM differ in their approach to PH law and how such differences affect their collaboration towards PH preparedness. METHODS: We conducted 144 semi-structured interviews with local and state PH and EM officials between April 2008 and November 2009. Thematic qualitative analysis in ATLAS.ti was used to extract characteristics of each agency's approach to PH legal preparedness. RESULTS: Two conflicting approaches to the law emerge. The PH approach is characterized by perceived uncertainty regarding legal authority over preparedness planning tasks; expectation for guidance on interpretation of existing laws; and concern about individual and organizational liability. The EM approach reveals perception of broad legal authority; flexible interpretation of existing laws; and ethical concerns over infringement of individual freedoms and privacy. CONCLUSIONS: Distinct interpretations of preparedness law impede effective collaboration for PH preparedness. Clarification of legal authority mandates, designation within laws of scope of preparedness activities and guidance on interpretation of current federal and state laws are needed.

An Emergency Preparedness Response to Opioid-Prescribing Enforcement Actions in Maryland, 2018-2019.

Federal and state enforcement authorities have increasingly intervened on the criminal overprescribing of opioids. However, little is known about the health effects these enforcement actions have on patients experiencing disrupted access to prescription opioids or medication-assisted treatment/medication for opioid use disorder. Simultaneously, opioid death rates have increased. In response, the Maryland Department of Health (MDH) has worked to coordinate mitigation strategies with enforcement partners (defined as any federal, state, or local enforcement authority or other governmental investigative authority). One strategy is a standardized protocol to implement emergency response functions, including rapidly identifying health hazards with real-time data access, deploying resources locally, and providing credible messages to partners and the public. From January 2018 through October 2019, MDH used the protocol in response to 12 enforcement actions targeting 34 medical professionals. A total of 9624 patients received Schedule II-V controlled substance prescriptions from affected prescribers under investigation in the 6 months before the respective enforcement action; 9270 (96%) patients were residents of Maryland. Preliminary data indicate fatal overdose events and potential loss of follow-up care among the patient population experiencing disrupted health care as a result of an enforcement action. The success of the strategy hinged on endorsement by leadership; the establishment of federal, state, and local roles and responsibilities; and data sharing. MDH's approach, data sources, and lessons learned may support health departments across the country that are interested in conducting similar activities on the front lines of the opioid crisis.

Roles and contributions of pharmacists in regulatory affairs at the Centers for Disease Control and Prevention for public health emergency preparedness and response.

OBJECTIVE: To provide a general description of the roles and contributions of three pharmacists from the Regulatory Affairs program (RA) at the Centers for Disease Control and Prevention (CDC) who are involved in emergency preparedness and response activities, including the 2009 pandemic influenza A (H1N1) public health emergency. SETTING: Atlanta, GA. PRACTICE DESCRIPTION: RA consists of a staff of nine members, three of whom are pharmacists. The mission of RA is to support CDC's preparedness and emergency response activities and to ensure regulatory compliance for critical medical countermeasures against potential threats from natural, chemical, biological, radiological, or nuclear events. CONCLUSION: RA was well involved in the response to the H1N1 outbreak through numerous activities, such as submitting multiple Emergency Use Authorization (EUA) requests to the Food and Drug Administration, including those for medical countermeasures to be deployed from the Strategic National Stockpile, and developing the CDC EUA website (www.cdc.gov/h1n1flu/eua). RA will continue to support current and future preparedness and emergency response activities by ensuring that the appropriate regulatory mechanisms are in place for the deployment of critical medical countermeasures from the Strategic National Stockpile against threats to public health.

Countermeasures Injury Compensation Program (CICP): administrative implementation, interim final rule. Interim final rule with request for comments.

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary is seeking public comments on this interim final rule.

Emergency Preparedness, Resilience and Response (EPRR).

As an organisation, locality or nation, there is a growing need to respond to a wide range of incidents and emergencies that could affect health and the care of patients. Responses to both domestic and international incidents have shown that collaboration, understanding and joint responses across organisations have improved the outcome of those affected by incidents which impact on health. Emergency response is something that is of increasing importance and has been tested on multiple occasions during recent events in the UK. Regarding health, the aim is to respond rapidly and efficiently, reducing potential morbidity and mortality to the lowest possible level in a given circumstance. This paper discusses what is meant by EPRR (Emergency, Preparedness, Resilience and Response), types of potential incidents, how we collectively prepare for responding and what has been learnt during recent events. It concludes with an outline of some selected current activity and highlights the likelihood of increased cross-sector working in EPRR.

Summary of latest NHS England Emergency Preparedness Resilience and Response (EPRR) guidance.

The National Health Service (NHS) England Emergency Preparedness, Resilience and Response Framework exists to provide a structure by which NHS England and NHS-funded bodies prepare for and respond to a range of emergencies. This framework exists to ensure that in emergencies the NHS retains the capability to deliver appropriate care to patients. Rather than dealing with individual scenarios, the framework aims to maintain the adaptability and capacity to deal with a variety of emergencies, their consequences and guide recovery plans. This paper summarises this guidance and elucidates the reasoning and mechanisms by which this care will be facilitated and delivered.

How a major incident plan can be used in an acute healthcare setting.

All NHS Trusts face a diverse range of potential threats and disruptions that can overwhelm the delivery of their routine healthcare services. Major incidents range from significant infrastructure failure to responding to significant casualty numbers from natural disasters and malicious incidents. Major incident plans are one of the body of documents that support trusts and in this instance acute NHS trusts in emergency preparedness. Major incident plans can be used as a reference point for staff of all disciplines, that is, clinical and non-clinical. Major incident plans incorporate the requirements of the Civil Contingencies Act 2004 for NHS-funded providers to ensure trusts conduct risk assessments, emergency planning, cooperating with other organisations, and internal and external communication. This paper summarises some of the key aspects in the construction and the use of major incident plans in acute care trusts.

COVID 19 and Nepal: Identification of Critical Public Health Measures.

The COVID-19 pandemic is unfolding at an unprecedented pace. The unprecedented threat provides an opportunity to emerge with robust health systems. Nepal has implemented several containment measures such as Rapid Response Team formulation; testing; isolation; quarantine; contact tracing;surveillance, establishment of COVID-19 Crisis Management Centre and designation of dedicated hospitals to gear up for the pandemic. The national public health emergency management mechanisms need further strengthening with the proactive engagement of relevant ministries; we need a strong, real-time national surveillance system and capacity building of a critical mass of health care workers; there is a need to further assess infection prevention and control capacity; expand the network of virus diagnostic laboratories in the private sector with adequate surge capacity;implement participatory community engagement interventions and plan for a phased lockdown exit strategy enabling sustainable suppression of transmission at low-level and enabling in resuming some parts of economic and social life.