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Liability Department of Health and Human Services (HHS)

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

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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

Harris Beach PLLC

PREP Act COVID 19 Liability Protections Continue Through HHS Amended Declaration

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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

Foley & Lardner LLP

Health Care Fraud Self Disclosure Protocol: You Discovered Misconduct… Now What?

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When a company decides to self-disclose misconduct (or conduct that may be construed as such) to the government, that decision triggers a stream of additional questions. In the weighty deliberations about whether and what to...more

Husch Blackwell LLP

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

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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

Jackson Lewis P.C.

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

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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

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

Holland & Knight LLP

The PREP Act and Vaccines Immunize, But Equally Well?

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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

More Than a Game Changer: Fourth Amendment to PREP Act Declaration Establishes Federal Jurisdiction, Bolsters Immunities, and...

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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

Faegre Drinker Biddle & Reath LLP

Department of Health and Human Services Amends PREP Act Declaration

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

Foley & Lardner LLP

PREP Act Immunity in the COVID-19 Era: Recent Decisions Impacting Your Defenses to Coronavirus-Related Claims

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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

Holland & Knight LLP

COVID-19 Vaccinations Are Coming, But What Will the PREP Act Immunize?

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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

Seyfarth Shaw LLP

Two New HHS Advisory Opinions Dramatically Illuminate the Wide Scope of PREP Act Immunity

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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

Seyfarth Shaw LLP

Third Amendment to PREP Act Declaration Further Expands Scope of Liability Immunity for Medical Countermeasures Against COVID-19

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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

Patterson Belknap Webb & Tyler LLP

HHS Amends Tort Immunity Declaration Under the PREP Act to Clarify that Immunity Extents to Products that “Limit the Harm”...

As we previously reported, on March 10, 2020, the Secretary of Health and Human Services, acting under the authority provided by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act), issued a Declaration...more

Seyfarth Shaw LLP

HHS Secretary Amends PREP Act Declaration to Clarify Definition of “Covered Countermeasures”

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On June 4, 2020, the Secretary for the US Department of Health and Human Services (HHS) issued a Notice of Amendment (Amendment) to his March 10, 2020 Declaration that had applied the federal immunities of the Public...more

Holland & Knight LLP

PREP Act: Liability Protection Is Available During COVID-19 Pandemic

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Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more

Troutman Pepper

HHS Issues Advisory Opinion Clarifying Prep Act Immunity

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In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more

Patterson Belknap Webb & Tyler LLP

HHS Issues Advisory Opinion Further Clarifying Scope of PREP Act Immunity

Since invoking its powers under the PREP Act last month to shield certain actors aiding in the fight against COVID-19 from tort liability for their efforts, the Department of Health and Human Services (“HHS”) has been...more

Akin Gump Strauss Hauer & Feld LLP

Federal Protections Against Liability for Businesses Combatting COVID-19

- Federal emergency authorities targeting COVID-19 provide important protections to businesses for certain actions in connection with the national response to the public health crisis. - The protections include immunity...more

Hogan Lovells

HHS guidance confers PREP Act immunity to pharmacists for certain COVID-19 tests

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On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more

King & Spalding

Tort Immunity under PREP Act and COVID-19 Response Declaration

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Pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), on March 17, 2020, the Secretary of Health and Human Services (“HHS”) published the Declaration Under the Public Readiness and Emergency...more

Hogan Lovells

Liability immunity under the PREP Act for COVID-19 countermeasures: what manufacturers need to know

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The Secretary of HHS issued a public health emergency declaration, effective February 4, 2020, regarding COVID-19. The impact of that declaration is to trigger certain targeted liability immunity provisions under the Public...more

McGuireWoods LLP

Countermeasures and Why They Matter for Liability During COVID-19

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Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more

Foley & Lardner LLP

OCR Clarifies Direct Liability for Business Associates under HIPAA

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On May 24, 2019, the Department of Health and Human Services Office for Civil Rights (OCR) issued a new fact sheet which lists the provisions of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (HIPAA)...more

Robinson+Cole Data Privacy + Security Insider

OCR Issues Fact Sheet Listing Circumstances in which Business Associates May Face Direct Liability for HIPAA Violations

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the Health and Human Service’s (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct...more

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