News & Analysis as of

Covered Entities Department of Health and Human Services (HHS) Health Care Providers

Baker Donelson

HRSA Announces 340B Rebate Pilot Program

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Structure & Timing of the Pilot Program - On August 1, 2025, the Health Resources and Services Administration (HRSA), administrator of the 340B Drug Pricing Program, announced its voluntary 340B Rebate Model Pilot Program in...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...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

Fisher Phillips

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

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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

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

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On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

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The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....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

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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

Holland & Knight LLP

Proposed HIPAA Security Rule Shifts Warrant Study and Comment

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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

Fox Rothschild LLP

New Year, New HIPAA Security Rules Headed Your Way

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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

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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

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

Davis Wright Tremaine LLP

Whether Naughty or Nice, Compliance Deadline for HIPAA Reproductive Care Privacy Is Coming to Town

We just want to provide a friendly reminder that, before key staff depart for the holidays, HIPAA covered entities and business associates should finalize their compliance with the 2024 HIPAA amendments related to...more

Holland & Knight LLP

HIPAA Tidings: A Look at OCR's Recent Enforcement Actions

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In addition to holiday celebrations, the month of December typically ushers in a final round of enforcement actions by the U.S. Department of Health and Human Services' (HHS) Office of Civil Rights (OCR), and 2024 is no...more

BakerHostetler

DSIR Deeper Dive: Tracking the Crackdown on Tracking/Pixel Technologies: Web Litigation and Regulatory Landscape - Part 2

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In the first part of this blog post, we looked into the OCR and FTC’s focus on third-party tracking technologies. We also reviewed the AHA Lawsuit and its impact for the use of tracking technologies. In this blog post, we...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

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

Justice Department Rule on Accessible Medical Diagnostic Equipment Carries Broad Implications for Healthcare Industry

The U.S. Department of Justice (DOJ) recently published a final rule on the accessibility of medical diagnostic equipment (MDE) and other accessibility-related practices that promises to have broad impact on the health care...more

Holland & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

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President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

Vorys, Sater, Seymour and Pease LLP

Action Required for HIPAA Covered Entities Regarding Reproductive Health Care Compliance

On April 22, 2024, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule)....more

Dentons

Ep. 37 – Updating HIPAA Policies to Address HHS’ New Reproductive Health Care Rule

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Effective December 23, 2024, HIPAA-covered entities and their business associates will be required to comply with new restrictions on how protected health information may be used and disclosed for certain purposes relating to...more

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