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Department of Health and Human Services (HHS) Healthcare Covered Entities

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

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

Holland & Hart LLP

Are You Ready for It? Section 1557's Upcoming Deadlines

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The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) published its final rules implementing the anti-discrimination provisions under Section 1557 of the Affordable Care Act (“Final Rule”) on May...more

Proskauer - Employee Benefits & Executive...

Deadlines Approaching for New ACA Section 1557 Nondiscrimination Requirements: Action Items for Covered Group Health Plans

Earlier this year, the Department of Health and Human Services (“HHS”) released a final rule under Section 1557 of the Affordable Care Act (“ACA”), which prohibits discrimination in health programs and activities. The 2024...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...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

Bass, Berry & Sims PLC

New Reproductive Health Care Privacy Final Rule: Key Compliance Steps and Dates

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In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization and subsequent state abortion bans, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services issued a...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

Health Care Compliance Association (HCCA)

OCR: Rule Halts Disclosures Under ‘Presumption of Lawfulness,’ Shares Model Attestation Form

Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more

Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...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

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

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On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...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

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

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In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Quarles & Brady LLP

Never Say Never Again: HHS Signals the Return of HIPAA Audit Program

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On February 12, 2024, the U.S. Department of Health and Human Services (“HHS”) published a notice in the Federal Register regarding reinstatement of the Health Information Portability and Accountability Act of 1996 (“HIPAA”)...more

McDermott Will & Emery

This Week in 340B: October 2023

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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

Pullman & Comley - Connecticut Health Law

Factors for Connecticut Health Providers to Consider When Responding to “Required by Law” Requests for Disclosure of Protected...

In June 2022, the HHS Office for Civil Rights issued new HIPAA Privacy Rule Guidance in response to the Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization and state legislation which followed the decision...more

Faegre Drinker Biddle & Reath LLP

Fifth Circuit Decision Motivates Covered Entities to Appeal Unreasonable Enforcement Outcomes

The United States Court of Appeals for the Fifth Circuit (the “Court”) vacated a $4,348,000 civil monetary penalty (“CMP”) imposed by the U.S. Department of Health and Human Services’ Office for Civil Rights (“HHS-OCR”) in...more

Sheppard Mullin Richter & Hampton LLP

Learning from the Mistakes of Others: OCR Releases Audit Report

The HHS Office for Civil Rights released, at the end of last year, findings from audits it conducted in 2016 and 2017 of 166 covered entities and 41 business associates. The report represents the periodic audit that the...more

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