No abstract

After 9/11 and the 2001 anthrax letters, it was evident that our nation's healthcare system was largely underprepared to handle the unique needs and large volumes of people who would seek medical care following catastrophic health events. In response, in 2002 Congress established the Hospital Preparedness Program (HPP) in the U.S. Department of Health and Human Services (HHS) to strengthen the ability of U.S. hospitals to prepare for and respond to bioterrorism and naturally occurring epidemics and disasters. Since 2002, the program has resulted in substantial improvements in individual hospitals' disaster readiness. In 2007, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) contracted with the Center for Biosecurity of the University of Pittsburgh Medical Center to conduct an assessment of U.S. hospital preparedness and to develop tools and recommendations for evaluating and improving future hospital preparedness efforts. One of the most important findings from this work is that healthcare coalitions-collaborative groups of local healthcare institutions and response agencies that work together to prepare for and respond to emergencies-have emerged throughout the U.S. since the HPP began. This article provides an overview of the HPP and the Center's hospital preparedness research for ASPR. Based on that work, the article also defines healthcare coalitions and identifies their structure and core functions, provides examples of more developed coalitions and common challenges faced by coalitions, and proposes that healthcare coalitions should become the foundation of a national strategy for healthcare preparedness and response for catastrophic health events.

No abstract

Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services' (HHS) Office of the General Counsel (OGC), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness (PREP) Act and Emergency Use Authorization (EUA) authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event (e.g., doxycycline mass dispensing preparedness for anthrax) and intra-event (e.g., 2009 H1N1 influenza pandemic response) activities.