News & Analysis as of

Final Rules Covered Entities Health Care Providers

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

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

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

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

Jenner & Block

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

Jenner & Block on

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

Verrill

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

Verrill on

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

Bricker Graydon LLP

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

Bricker Graydon LLP on

Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more

Goodwin

HHS-OCR Publishes Final HIPAA Privacy Rule Expanding Reproductive Health Care Privacy and Further Supporting Patient...

Goodwin on

On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more

McDermott Will & Emery

The Impact of the ACA 1557 Final Regulations on Gender-Affirming Care

Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age or disability, or any combination thereof, in a health program or activity, any part of which is...more

Fenwick & West LLP

New Rule to Support Reproductive Health Care Privacy Under HIPAA

Fenwick & West LLP on

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) implemented a Final Rule enhancing the HIPAA Privacy Rule to safeguard reproductive health care privacy. Given the recent Dobbs decision, HHS expressed...more

Stinson - Benefits Notes Blog

HHS Supports Reproductive Health Care Privacy by Modifying the HIPAA Privacy Rule

The Department of Health and Human Services’ (“HHS”) Office for Civil Rights recently published a final rule (the “Final Rule“) which provides additional privacy protections related to the use and disclosure of reproductive...more

Epstein Becker & Green

HHS Publishes Final Rule to Support Reproductive Health Care Privacy

Epstein Becker & Green on

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

BakerHostetler

The Long-Awaited Part 2 Modifications Are Finalized with New Obligations for Part 2 Providers and Less Friction for Sharing...

BakerHostetler on

On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Seyfarth Shaw LLP

Transgender Patients Remain Protected: District Court Blocks HHS Rule From Taking Effect

Seyfarth Shaw LLP on

Seyfarth Synopsis: A Federal Court has temporarily enjoined the Trump administration from putting into effect its recent rule that strips the Affordable Care Act of its gender identity protections....more

Holland & Knight LLP

HHS Issues Final Rule on Section 1557

Holland & Knight LLP on

Under Section 1557 of the Affordable Care Act (Section 1557), "covered entities," which were defined as health programs or activities that receive "federal funding" from the U.S. Department of Health and Human Services (HHS)...more

King & Spalding

HHS Issues Important Notice That It Will Not Enforce Certain Fee Limitations On Individuals' Requests To Transmit Health Records...

King & Spalding on

On January 28, 2020, the Department of Health and Human Services (“HHS”) issued an announcement of financial importance to covered entities and business associates that produce copies of medical records to patients and third...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

King & Spalding on

On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

Verrill

No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019

Verrill on

The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more

Holland & Knight LLP

340B Drug Pricing Program Final Rule Delayed … Again

Holland & Knight LLP on

In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule,...more

Fisher Phillips

Federal Judge Blocks Transgender Protections

Fisher Phillips on

On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more

Epstein Becker & Green

Five Key Issues Impacting Health Care Employers

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Employers in the health care industry are likely to face significant changes under President-elect Donald J. Trump’s administration and should expect a healthy dose of uncertainty for the next few months. During his campaign,...more

Fisher Phillips

The Clock Is Ticking – ACA Nondiscrimination Rules Will Take Effect January 1

Fisher Phillips on

Earlier this year, the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) published a final rule to implement Section 1557 of the Affordable Care Act (ACA). Most prominently, this rule...more

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