Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
What Health Care Providers and Facilities Should Know About the PREP Act's "Covered Countermeasures"
COVID-19 Hospice How-To Series: The Latest on Testing and Vaccinating Employees
During the past 12 months, we’ve published several articles on the 10 March 2020, Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19 as well as covering the five amendments to the PREP...more
The Public Readiness and Emergency Preparedness Act (PREP Act) may provide immunity to product manufacturers and premises owners who face liability from their administration or use of antivirals, drugs, biologics,...more
The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more
Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department...more
Individuals and organizations that want to play a role in administering countermeasures to combat a disease or combat a public health emergency, such as COVID-19, worry about the potential legal exposure. The choice to...more
On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity...more
The Department of Health and Human Services (HHS) is working to dramatically increase the number of available vaccinators who may administer COVID-19 shots. At a press briefing held on January 27, 2021, White House...more
The executive and judicial branches do not see eye-to-eye on the scope of PREP Act immunity. The U.S. Department of Health and Human Services (HHS), under the current administration, has taken umbrage at how lower courts have...more
The US Department of Health and Human Services (“HHS”) issued an Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete...more
Back in March, we wrote about how the Department of Health and Human Services (HHS) had extended the Public Readiness and Emergency Preparedness (PREP) Act to grant immunity to “Covered Persons” providing “Covered...more
On December 3, 2020, the federal government took a significant step to reduce barriers to healthcare practitioners’ ability to provide COVID-19-related telehealth services across state lines by amending its previous...more
On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide...more
In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through...more
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act....more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more
On December 3, 2020, the Secretary of the Department of Health and Human Services issued a fourth amended PREP Act declaration expanding the scope of immunity for covered entities engaged in the provision of goods and...more
On December 3, 2020, in anticipation of one or more forthcoming COVID-19 vaccines, the U.S. Department of Health and Human Services (HHS) purported to broadly expand civil immunity from tort claims related to the manufacture,...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) amended its Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19 in order to clarify...more
On March 25, 2020, we reported that the Department of Health and Human Services (HHS) had extended the Public Readiness and Emergency Preparedness (“PREP”) Act to provide immunity to “Covered Persons” providing “Covered...more
The Public Readiness and Emergency Preparedness Act, Public Law 109-148, Div. C, § 2 (2005) (PREP Act), as amended, authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to...more
The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in...more
To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10,...more
On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more