News & Analysis as of

Department of Health and Human Services (HHS) Covered Entities Health Insurance Portability and Accountability Act (HIPAA)

Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Polsinelli on

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Wyrick Robbins Yates & Ponton LLP

U.S. District Court Vacates HIPAA Reproductive Health Privacy Rule Nationwide

A U.S. District Court in the Northern District of Texas has vacated most of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (the “Rule”) in the case of Purl v. DHHS. The ruling, which has immediate...more

Husch Blackwell LLP

Federal Court Vacates 2024 HIPAA Reproductive Health Privacy Rule: Key Impacts for Covered Entities and NPP Compliance

Husch Blackwell LLP on

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a decision in Carmen Purl, et al. v. United States Department of Health and Human Services, et al., vacating nearly all of the 2024 HIPAA...more

Proskauer - Employee Benefits & Executive...

District Court Vacates HIPAA Reproductive Health Care Rule

Last month, a federal district court in Texas vacated portions of the HIPAA final rule that added heightened protections for reproductive health care information (the “Final Rule”). Purl, et al. v. U.S. Department of Health...more

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

Fisher Phillips

Reproductive Healthcare Privacy Rule Struck Down Nationwide by Texas Judge: What Providers and Employer-Sponsored Health Plans...

Fisher Phillips on

A federal judge in Texas just tossed out Biden-era reproductive healthcare privacy protections, halting a 2024 final rule with nationwide effect. The rule, which largely took effect in December and created new HIPAA privacy...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

Ogletree, Deakins, Nash, Smoak & Stewart,...

2025 Enforcement Trends: Risk Analysis Failures at the Center of HHS’s Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability and Accountability Act (HIPAA) resolution...more

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Davis Wright Tremaine LLP

New Administration Outlook: Trump Orders and the Impact on Reproductive Healthcare

On January 24, 2025, President Trump issued an Executive Order, titled "Enforcing the Hyde Amendment," revoking President Biden's two Executive Orders 14076 (July 8, 2022) and 14079 (August 3, 2022) that federally protected...more

Faegre Drinker Biddle & Reath LLP

Proposed HIPAA Security Rule Updates — Implications for Covered Entities and Their Information Security Programs

On January 6, 2025, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking (Proposed Rule) updating the Health Insurance Portability and...more

King & Spalding

OCR Proposes Updates to Strengthen the HIPAA Security Rule

King & Spalding on

On December 27, 2024, the Office for Civil Rights (OCR) at HHS issued a Notice of Proposed Rulemaking (the Proposed Rule) intended to update the Security Rule under the Health Insurance Portability and Accountability Act...more

Robinson+Cole Health Law Diagnosis

What to Know About the HHS HIPAA Security Standards Proposal

At the close of 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (the Proposed Rule) to amend the Security Rule regulations established...more

McCarter & English, LLP

Proposed HIPAA Security Rule Amendments: Not Too Soon to Take Stock

On January 6, 2025 the U.S. Department of Health and Human Services published a Proposed Rule (90 FR 898) to strengthen the HIPAA Security Rule and afford greater cybersecurity protections for electronic protected health...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

Troutman Pepper Locke on

On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more

Mintz - Privacy & Cybersecurity Viewpoints

Happy 2025: OCR Proposes Sweeping HIPAA Security Rule Amendments

In response to an alarming increase in the size and frequency of large-scale data breaches involving protected health information, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) dropped a bit of...more

Holland & Knight LLP

Proposed HIPAA Security Rule Shifts Warrant Study and Comment

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rulemaking (NPRM) that strengthens the Security Rule of the Health Insurance Portability and Accountability Act (HIPAA), which, if...more

Sheppard Mullin Richter & Hampton LLP

HHS’ Last-Minute Holiday Gift: Proposed Changes to the HIPAA Security Rule

The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more

Fox Rothschild LLP

New Year, New HIPAA Security Rules Headed Your Way

Fox Rothschild LLP on

What better way to welcome the new year than with proposed new HIPAA Security Rules? As 2024 came to an end, the U.S. Department of Health and Human Services announced new proposed regulations to strengthen cybersecurity and...more

Morgan Lewis

HHS Proposes Major 2025 Update to HIPAA Security Rule

Morgan Lewis on

For the first time in 11 years, the US Department of Health and Human Services (HHS) has proposed updating the Security Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Proposed Rule, to...more

Holland & Knight LLP

Big Changes Proposed for the HIPAA Security Rule

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) has issued an unpublished Notice of Proposed Rulemaking (NPRM) that strengthens the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and, if...more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Stevens & Lee

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

Stevens & Lee on

Around the corner is the Dec. 23 deadline to have your organization bring its HIPAA Notice of Privacy Practices into compliance with the U.S. Department of Health & Human Services’ Office for Civil Rights Final Rule modifying...more

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