News & Analysis as of

Public Readiness and Emergency Preparedness Act (PREP Act) Department of Health and Human Services (HHS)

Harris Beach Murtha PLLC

New York Medical and Life Sciences: Year in Review 2023

From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

King & Spalding

HHS Announces the End of the COVID-19 Public Health Emergency

King & Spalding on

On May 9, 2023, HHS released a fact sheet announcing the expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. HHS also provided information on changes to the healthcare flexibilities issued during the...more

Dorsey & Whitney LLP

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

Dorsey & Whitney LLP on

For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more

Harris Beach Murtha PLLC

PREP Act COVID 19 Liability Protections Continue Through HHS Amended Declaration

With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the...more

Holland & Hart LLP

Public Health Emergency Ends May 11, 2023: Check Your Readiness

Holland & Hart LLP on

After three years, the federal public health emergency (PHE) will expire May 11, 2023. Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to: ...more

Harris Beach Murtha PLLC

PREP Act Preemption: “There is no COVID-19 Exception to Federalism”

Harris Beach Murtha PLLC on

When the estates of nursing home residents who died from COVID-19 brought negligence and wrongful death lawsuits in New Jersey state court, defendant nursing homes removed the suits to federal court under the Public Readiness...more

Woods Rogers

Employers Likely Not Liable for Vaccine-Related Injuries to Employees

Woods Rogers on

Vaccine mandates are the subject of much discussion and controversy in nearly every industry, both in America and abroad.  As protests rage across the country, many workers question the ability of employers to mandate...more

Hogan Lovells

U.S. courts continue to apply narrower view of PREP Act immunity

Hogan Lovells on

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

Husch Blackwell LLP

PREP Act Offers Immunity To Product Manufacturers And Premises Owners From COVID-19 Liability

Husch Blackwell LLP on

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

Harris Beach Murtha PLLC

HHS Further Amends Declaration Under the PREP Act to Address Influenza and COVID-19 Impact and Add Pharmacist Vaccinators

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

Mitchell, Williams, Selig, Gates & Woodyard,...

Renewal of Federal COVID-19 Public Health Emergency

On July 19, 2021, the U.S. Department of Health & Human Services (HHS) issued a Renewal of Determination that a Public Health Emergency Exists extending the federal COVID-19 public health emergency (PHE) for another ninety...more

Morgan Lewis - Health Law Scan

Additional PREP Act Amendments Accommodate Vaccination Administration Needs

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

Seyfarth Shaw LLP

Seventh Amendment to PREP Act Declaration Further Increases the Pool of Authorized COVID-19 Vaccinators

Seyfarth Shaw LLP on

On March 12, 2021, the US Department of Health and Human Services (“HHS”) amended, its Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for the seventh time. The Seventh Amendment expands the...more

Faegre Drinker Biddle & Reath LLP

February Regulatory and Legislative Update

This edition of the “Government Contracts Regulatory and Legislative Update” offers a summary of and insight into the relevant industry developments that occurred during the month of February....more

Jackson Lewis P.C.

PREP Act And COVID-19 Vaccinations: Health And Human Services Department Clears Way To Assist

Jackson Lewis P.C. on

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

Hogan Lovells

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

Hogan Lovells on

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

Seyfarth Shaw LLP

Fifth Amendment to PREP Act Declaration Expands the Ranks of Health Care Providers Authorized to Administer COVID-19 Vaccines

Seyfarth Shaw LLP on

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”), which expands the categories of...more

Rivkin Radler LLP

HHS Relaxes Rules On Administering COVID-19 Vaccines

Rivkin Radler LLP on

On January 28, the U.S. Department of Health and Human Services (HHS) announced that it has amended the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand the types of providers that...more

King & Spalding

HHS Expands Categories of Persons Covered Under the PREP Act Who Can Administer COVID-19 Vaccine

King & Spalding on

On January 28, 2021, HHS issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), expanding the categories of persons able to prescribe, dispense, and administer...more

Robinson+Cole Health Law Diagnosis

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act

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

ArentFox Schiff

HHS to Permit Retired and Out-of-State Nurses and Doctors to Administer COVID-19 Vaccines

ArentFox Schiff on

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

Harris Beach Murtha PLLC

HHS Further Amends Declaration Under the PREP Act to Expand COVID-19 Vaccinators

The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures...more

Faegre Drinker Biddle & Reath LLP

HHS Amends PREP Act Declaration to Facilitate Vaccine Rollout

On January 28, 2021, Norris Cochran, the acting secretary of the U.S. Department of Health and Human Services (HHS), amended the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical...more

Holland & Knight LLP

The PREP Act and Vaccines Immunize, But Equally Well?

Holland & Knight LLP on

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

Seyfarth Shaw LLP

New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act’s Defenses in...

Seyfarth Shaw LLP on

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

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