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Covered Entities Healthcare Health Care Providers

Shipman & Goodwin LLP

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

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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

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

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

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

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 & Emery

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

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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

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

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

Health Care Compliance Association (HCCA)

HHS Abandons Appeal in Public Website Pixel Case, But CEs and BAs Should Expect Continued Scrutiny

The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more

Jenner & Block

Client Alert: The Department of Health and Human Services Issues HIPAA Final Rule Providing Additional Reproductive Health...

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On April 26, 2024, the Department of Health and Human Services (HHS) published the final HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule). The Final Rule became effective June 25, 2024....more

Health Care Compliance Association (HCCA)

Reproductive healthcare and HIPAA: New compliance obligations cause tension with courts, government agencies

The U.S. Supreme Court’s holding in Dobbs v. Jackson Women’s Health Organization has had a seismic impact on the landscape of U.S. healthcare. Among other effects, it has created new friction between states. With stark...more

McDermott Will & Emery

This Week in 340B: August 2 - 7, 2023

This weekly series provides brief summaries 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

Verrill

HHS Issues Model Attestation Required by Final HIPAA Regulations Supporting Reproductive Health Care Privacy

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On April 26, 2024, the U.S. Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) published Final Regulations under HIPAA’s Privacy Rule introducing greater protections for information related to...more

Ward and Smith, P.A.

Navigating the National Practitioner Data Bank: A Guide for Healthcare Professionals (NPDB or Data Bank).

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Few aspects of the healthcare regulatory apparatus evoke more confusion and dread for healthcare practitioners than the National Practitioner Data Bank (NPDB or Data Bank).  Being reported to the Data Bank is often regarded...more

McDermott Will & Emery

This Week in 340B: May 28 – June 3, 2024

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 & Emery

This Week in 340B: May 21 – May 27, 2024

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

Wiley Rein LLP

Manufacturers Are “Winning” in the 340B Drug Discount Dispute

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Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more

Epstein Becker & Green

HHS Publishes Final Rule to Support Reproductive Health Care Privacy

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The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the...more

Sheppard Mullin Richter & Hampton LLP

DHHS Bolsters Non-Discrimination Protections for Recipients of Covered Health Care Services and Activities

In a Final Rule issued on May 6, 2024, the U.S. Department of Health and Human Services (“DHHS”) finalized regulations implementing Section 1557 of the Affordable Care Act (“Section 1557”). The Final Rule updates and...more

Health Care Compliance Association (HCCA)

‘I Will Not Rest’; ‘I Am All In’: Remarkable Breach Hearing Sees Pledges by UHG CEO, Sen. Wyden

United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Epstein Becker & Green

In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute

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On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more

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