In 2005, Congress passed into law the , commonly referred to as the PREP Act. The PREP Act provides limited legal liability in order to facilitate the development and implementation of medical countermeasures during a federally declared public health emergency and has been recently amended to provide immunity to providers who administer the COVID-19 vaccine, in addition to other clarifying directives.
The PREP Act provides “liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.”
The law and its broad application were relatively obscure until the advent of the COVID-19 pandemic when, on March 17, 2020, U.S. HHS Secretary Alex Azar issued a declaration under the Act to provide limited immunity for countermeasures necessary to combat the virus.
Since then, four amendments to the declaration have been issued to clarify what countermeasures and covered persons are under the Act's limited liability umbrella, ranging from the use of telehealth to respirators.
On December 3, 2020, Secretary Azar declared that liability protections will be afforded to those Covered Persons who “manufacturer, test, develop, distribute, administer, or use” the COVID-19 vaccine. The liability protections were triggered when the vaccine itself was defined as an approved Covered Countermeasure. In addition, the scope of the PREP Act was clarified to acknowledge that there are situations when not administering a Covered Countermeasure is appropriate and can fall within the Act’s liability protections.
For purposes of administering the COVID-19 vaccine, the amended declaration includes in its definition of Covered Persons as persons who are authorized under law to “prescribe, administer, deliver, distribute or dispense” the vaccine and includes pharmacists who meet specific training requirements.
The liability protections for COVID-19 vaccine countermeasures began on December 3, 2020, through the final day of the federally declared emergency or October 1, 2024, whichever date occurs first.
In addition to PREP Act protections, on January 19, 2021, the Office for Civil Rights announced that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA rules on covered healthcare providers or their business associates in connection with the good faith use of online or web-based scheduling applications for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency. The enforcement discretion is retroactive effect to December 11, 2020. Read the full enforcement discretion document here.