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Department of Health and Human Services (HHS) Liability Health Care Providers

Pietragallo Gordon Alfano Bosick & Raspanti,...

Hidden Dangers Lurking in Corporate Integrity Agreements

When I litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ), it was common practice for settlements to require Corporate Integrity Agreements (CIAs) setting forth ongoing duties and responsibilities...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

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

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?

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

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

Seyfarth Shaw LLP on

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

Holland & Knight LLP

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

Holland & Knight LLP on

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

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

Foley & Lardner LLP

OCR Clarifies Direct Liability for Business Associates under HIPAA

Foley & Lardner LLP on

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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