Legal Authority

Public Health Service Act

The PHS Act forms the foundation of HHS’ legal authority for responding to public health emergencies. Among other things, it authorizes the HHS Secretary to lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Framework; to direct the U.S. PHS and other components of the Department to respond to a public health emergency; to declare a public health emergency (PHE) and take such actions as may be appropriate to respond to the PHE consistent with existing authorities; to assist states in meeting health emergencies; to control communicable diseases; to maintain the Strategic National Stockpile; to provide for the operation of the National Disaster Medical System; to establish and maintain a Medical Reserve Corps; and to potentially provide targeted immunity for covered countermeasures to manufacturers, distributors, certain classes of people involved in the administration of a program to deliver covered treatments to patients, and their employees. The PHS Act was amended by the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, by the 21st Century Cures Act of 2016, and most recently by the Pandemic and All Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), which have broad implications for the Department’s preparedness and response activities.

Social Security Act

The Social Security Act authorizes Medicare, Medicaid,  the Children’s Health Insurance  Program (CHIP), and social services programs of the Department. It authorizes the Secretary, among other things, to temporarily modify or waive certain Medicare, Medicaid, CHIP, and HIPAA requirements when the Secretary has declared a public health emergency and the President has declared an emergency or a major disaster under the Stafford Act or a national emergency under the National Emergencies Act.

Federal Food, Drug and Cosmetic Act

The Federal Food, Drug, and Cosmetic Act is the foundation for FDA’s authority and responsibility to protect and promote the public health by, among other things, ensuring  the safety and effectiveness of human and veterinary drugs, biological products, and medical devices; and ensuring the safety and security of our nation’s food supply. When certain conditions have occurred, it authorizes the Secretary to declare an emergency justifying emergency use authorization (EUA) of unapproved drugs, devices, or biological products, or emergency use authorization of approved drugs, devices, or biological products for an unapproved use. For more information about EUA, please see Food and Drug Administration, Emergency Use Authorization.

Robert T. Stafford Disaster Relief and Emergency Assistance Act 

At the request of the Governor of an affected State, or a Chief Executive of an affected Indian Tribe, the President may declare a major disaster or emergency if an event is beyond the combined response capabilities of the State, Tribal, and jurisdictional governments. Among other things, this declaration allows Federal assistance to be mobilized and directed in support of State, Tribal, and jurisdictional response efforts. Under the Stafford Act (42 USC Chapter 68), the President can also declare an emergency without a Gubernatorial request if primary responsibility for response rests with the Federal Government because the emergency involves a subject area for which the United States exercises exclusive responsibility and authority. In addition, in the absence of a specific request, the President may provide accelerated Federal assistance and Federal support where necessary to save lives, prevent human suffering, or mitigate severe damage, and notify the State of that activity.