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Healthcare Covered Entities

Goodwin

New Texas Law Regulates Use of EHRs and AI Tools

Goodwin on

Texas Senate Bill (SB) 1188 is effective September 1, 2025, and imposes new legal obligations on certain covered entities, including healthcare practitioners, regarding the privacy, security, and processing of electronic...more

Dentons

Ep. 76 – Back to Basics: HIPAA Patient Rights – Requesting Restrictions

Dentons on

We’ve reached the final episode in our Back-to-Basics: HIPAA Edition series! Over the past few weeks, we’ve explored some of the fundamental patient rights under HIPAA, including: The right to access their PHI...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

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...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

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

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

Sheppard Mullin Richter & Hampton LLP

Montana Amends Law to Cover Collection and Use of Neural Data

Montana recently revised its Genetic Information Privacy Act to address neural data. The law went into effect in 2023, and applies to both entities that offer genetic testing services as well as entities that use genetic...more

McDermott Will & Schulte

This Week in 340B: May 13 – 19, 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

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 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

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

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

McDermott Will & Schulte

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

Epstein Becker & Green

Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook

Epstein Becker & Green on

As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...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

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

McDermott Will & Schulte

HHS Letter Reiterates Expectations for Language Accessibility

McDermott Will & Schulte on

On December 5, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a “Dear Colleague” letter reiterating obligations that covered entities have under the May 2024 final rule related...more

McDermott Will & Schulte

This Week in 340B: December 3 – 9, 2024

McDermott Will & Schulte on

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

Brooks Pierce

OIG Recommends Changes to HIPAA Audit Program to Strengthen Data Protections, Implications for Regulated Entities

Brooks Pierce on

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is required by law to perform periodic audits of covered entities and business associates to ensure their compliance with HIPAA Security Rule...more

McDermott Will & Schulte

California Ballot Proposition 34 Targets Spending by Certain 340B Covered Entities

McDermott Will & Schulte on

Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount...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

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Health Care Compliance Association (HCCA)

BAAs: If and when third parties receiving PHI for research qualify as BAs under HIPAA

A business associate agreement (BAA) is a written contract between a covered entity (CE) and a business associate (BA) that—among other requirements—(1) establishes the permitted and required uses and disclosures of protected...more

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