News & Analysis as of

Covered Entities Health Care Providers

Dentons

Ep. 75 – Back to Basics: Understanding a Patient’s Right to Request an Accounting of Disclosures

Dentons on

Our Back-to-Basics series celebrates back-to-school season by taking a fresh look at some basic compliance obligations....more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program (Updated)

As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more

BakerHostetler

Texas Passes New Law Regulating Electronic Health Records and the Use of AI by Healthcare Professionals

BakerHostetler on

On June 20, Texas enacted S.B. 1188, joining only a handful of states that are taking artificial intelligence (AI) and data offshoring restrictions into their own hands. The law applies to most healthcare providers and all...more

Dentons

Ep. 74 - Back to Basics: Understanding a Patient’s Right to Request PHI Amendments

Dentons on

It is back-to-school season, and The Healthcare Compliance Pod is going back to school too! Each week in August, we’re discussing one fundamental basic compliance obligation for healthcare providers, centered exclusively on...more

Baker Donelson

HRSA Announces 340B Rebate Pilot Program

Baker Donelson on

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

Husch Blackwell LLP on

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

BCLP

The HIPAA Trap: Are You Actually a Covered Entity?

BCLP on

Whenever the topic of health and medical data comes up, the prevailing assumption often is that any of this information is subject to the federal Health Insurance Portability and Accountability Act (HIPAA) just by virtue of...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on

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

Dinsmore & Shohl LLP on

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

Shipman & Goodwin LLP

A Balancing Act: Privacy Issues And Responding to A Federal Subpoena Investigating Transgender Care

Shipman & Goodwin LLP on

On Wednesday, July 9, 2025, the United States Department of Justice (“DOJ”) issued more than 20 subpoenas to physicians and clinics (the “Providers”) who provide gender-affirming care to transgender youth. According to the...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

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

Health Care Compliance Association (HCCA)

$1.5M Warby Parker Fine a Holdover; OCR Focuses On Men in Sports, Antisemitism, ‘Biological Truth’

Nearly six years to the day that Warby Parker reported a breach affecting nearly 200,000 individuals, the HHS Office for Civil Rights (OCR) imposed a $1.5 million fine on the eyewear giant. Investigated by OCR under the Biden...more

McDermott Will & Schulte

This Week in 340B: January 21 – 27, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

Baker Donelson on

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

Fisher Phillips on

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

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

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

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

Bodman

HIPAA and Reproductive Health: Certain Updates Take Effect December 23, 2024

Bodman on

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule regulations have been updated to impose additional requirements on covered entities to safeguard the privacy of reproductive health related...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

574 Results
 / 
View per page
Page: of 23

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide