News & Analysis as of

Covered Entities Department of Health and Human Services (HHS) Vacated

Warner Norcross + Judd

Federal Court Vacates HIPAA Rule on Reproductive Health Care Privacy

Warner Norcross + Judd on

Last year, the federal Office for Civil Rights (OCR) modified the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen protections for reproductive health care information (the “2024 Rule”)....more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

Seyfarth Shaw LLP on

In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

Bass, Berry & Sims PLC

Court Vacates HIPAA 2024 Final Rule Related to Reproductive Health Care Privacy

Bass, Berry & Sims PLC on

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more

Faegre Drinker Biddle & Reath LLP

Fifth Circuit Decision Motivates Covered Entities to Appeal Unreasonable Enforcement Outcomes

The United States Court of Appeals for the Fifth Circuit (the “Court”) vacated a $4,348,000 civil monetary penalty (“CMP”) imposed by the U.S. Department of Health and Human Services’ Office for Civil Rights (“HHS-OCR”) in...more

Bass, Berry & Sims PLC

Perfection Not Required: Fifth Circuit Vacates HHS OCR $4.3 Million Penalty for Potential Data Breach Case

Bass, Berry & Sims PLC on

On January 14, the Fifth Circuit vacated the University of Texas M.D. Anderson Cancer Center’s (M.D. Anderson) $4.3 million fine for HIPAA violations arising from its loss of more than 35,000 individuals’ protected health...more

Arnall Golden Gregory LLP

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Foley & Lardner LLP on

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

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