On June 11, in response to the global spread of a new strain of influenza, the World Health Organization (WHO) raised the level of influenza pandemic alert to phase 6, the highest level, which indicates the start of an actual pandemic. This change in alert level reflected the spread of the new virus, not its severity. In late April 2009, human cases of infection with a novel influenza A(H1N1) virus were identified. Since then, the virus has become widespread. Although currently the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, the virus and its effects may change over time. This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues. In response to public health threats, the Secretary of the Department of Health and Human Services (HHS) can provide a considerable degree of assistance to states through the Secretary's general, non-emergency authorities. For example, upon the request of a state health official, and without the involvement of the President, the Centers for Disease Control and Prevention (CDC) can provide financial and technical assistance to states for outbreak investigation and disease control activities. These activities are carried out under the Secretary's general authority to assist states at 42 U.S.C. §§ 243(c) and 247b. There are also a number of authorities in the Public Health Service (PHS) Act that allow the Secretary of HHS to take certain actions in the face of a "public health emergency." The principal authority is in Section 319 of the PHS Act, 42 U.S.C. § 247d(a), which states that If the Secretary determines, after consultation with such public health officials as may be necessary, that—(1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). The then-Acting HHS Secretary issued a nationwide public health emergency declaration in response to human infections from the influenza A(H1N1) virus on April 26, 2009. Making such a determination enables the Secretary to take three types of actions that can be especially useful for dealing with an emerging influenza outbreak. First, such a determination authorizes the Secretary to draw from a special emergency fund. Second, it is one of three events that can lead to the issuance of Emergency Use Authorizations under the Federal Food, Drug, and Cosmetic Act to allow for the use of unapproved medical treatments and tests, under specified conditions, if needed during an incident. Third, if there is a concurrent declaration pursuant to either the Stafford Act or the National Emergencies Act, the Secretary is authorized to waive or modify temporarily certain administrative requirements under Section 1135 of the Social Security Act, as necessary to ensure that sufficient healthcare items and services are available to meet the needs of individuals enrolled in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP), and that providers of such services in good faith who are unable to comply with certain statutory requirements are exempted from sanctions for noncompliance, absent fraud or abuse. With respect to the 2009 influenza pandemic, and pursuant to the Secretary's declaration of a public health emergency under Section 319 of the PHS Act, the Public Health Emergency Fund is available (but is currently unfunded); certain Emergency Use Authorizations have been granted by FDA; and, once the President declared a national emergency under the National Emergencies Act, the Secretary authorized waivers and modifications under Section 1135 of the Social Security Act. The National Emergencies Act (NEA) authorizes the President to declare a national emergency and activate existing statutory provisions that authorize the exercise of special or extraordinary power. The NEA does not provide any specific emergency authority on its own, but relies upon emergency authorities provided in other statutes. For example, a national emergency declaration under the NEA could authorize the Secretary of HHS to deploy officers in the Commissioned Corps of the Public Health Service to agencies outside of HHS in response to an urgent or emergency public health care need. Emergency statutory provisions are not activated automatically, but must be specifically identified in the President's declaration before they may be given effect. President Barack Obama declared a state of national emergency pursuant to the National Emergencies Act on October 23, 2009. Specifically, the President proclaimed that because "the rapid increase in illness across the nation may overburden health care resources and ... the temporary waiver of certain standard Federal requirements may be warranted in order to enable U.S. health care facilities to implement emergency operations plans, the 2009 H1N1 influenza pandemic in the United States constitutes a national emergency." The President further authorized the Secretary of HHS to "exercise the authority under section 1135 of the Social Security Act to temporarily waive or modify certain requirements of the Medicare, Medicaid, and State Children's Health Insurance programs and of the Health Insurance Portability and Accountability Act Privacy Rule throughout the duration of the public health emergency declared in response to the 2009 H1N1 influenza pandemic." A presidential declaration under the Stafford Act triggers federal emergency authorities that are independent of the Secretary's public health emergency authorities. Declarations under the Stafford Act fall into two categories: emergency declarations and major disaster declarations. As of this point in time, there have been no Stafford Act declarations pertaining to the 2009 influenza pandemic. A presidential emergency declaration under the Stafford Act authorizes the President to direct federal agencies to support state and local emergency assistance activities; coordinate disaster relief provided by federal and non-federal organizations; provide technical and advisory assistance to state and local governments; provide emergency assistance through federal agencies; remove debris through grants to state and local governments; provide assistance to individuals and households for temporary housing and uninsured personal needs; and assist state and local governments in the distribution of medicine, food, and consumables. The total amount of assistance available is limited in an emergency declaration to $5 million, "unless the President determines that there is a continuing need; Congress must be notified if the $5 million ceiling is breached." Emergency declarations under the Stafford Act in the event of an outbreak of infectious disease are not unprecedented. In 2000, the detection of West Nile virus in New York and New Jersey was used as the basis of an emergency declaration under the Stafford Act. However, there may be uncertainty regarding whether a flu pandemic, or any outbreak of infectious disease, would be eligible for major disaster assistance under the Stafford Act. A major disaster declaration authorizes the President to offer all the assistance authorized under an emergency declaration, and further authorizes funds for the repair and restoration of federal facilities, unemployment assistance, emergency grants to assist low-income migrant and seasonal farm workers, food coupons and distribution, relocation assistance, crisis counseling assistance and training, community disaster loans, emergency communications, and emergency public transportation. Additionally, the total amount of assistance provided in a major disaster declaration is not subject to a ceiling in the same way as under an emergency declaration. The authority of the President to declare a major disaster under the Stafford Act in response to a flu pandemic may be subject to some debate and likely depends upon whether a flu pandemic would qualify as a "natural catastrophe" under the Stafford Act. FEMA has historically excluded biological incidents from major disaster declarations under the Stafford Act, but executive policy under the Bush administration appeared to consider biological incidents, or at least flu pandemics, to be eligible for major disaster assistance. Although there are differences between the types and amounts of assistance that are authorized by an emergency or major disaster declaration, either declaration would activate the Secretary's waiver or modification authority, if concurrent with a public health emergency declaration. There have been no declarations issued under the Stafford Act with respect to the current pandemic. Section 1135 of the Social Security Act was added by Section 143 of P.L. 107-188 , the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, to authorize the HHS Secretary to waive certain regulatory requirements related to the provision of health care services when the President has declared an emergency or major disaster pursuant to either the NEA or the Stafford Act, and the Secretary of HHS has declared a public health emergency. Waivers under Section 1135 involve administrative requirements principally relating to reimbursement through the Medicare and Medicaid programs, in order to facilitate the provision of health care items and services by providers in an emergency area subject to the concurrent declarations. An emergency area and an emergency period are defined in Section 1135 as the geographic area in which and time period during which there exists an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Stafford Act concurrently with a public health emergency declared by the Secretary pursuant to Section 319 of the PHS Act. If Section 1135 conditions are met, then health care facilities may ask the Secretary for "1135 waivers" in response to particular needs within the geographic and temporal areas of the emergency declarations. Generally, these waivers and modifications may assist patients who must be relocated due to the inaccessibility of health care facilities in the emergency area, allow beneficiaries to receive services despite having lost their documentation of eligibility, and allow providers to provide services in alternate temporary facilities.