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Regulatory Requirements Department of Health and Human Services (HHS)

McDermott Will & Schulte

HHS announces information blocking enforcement “crackdown”

The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more

Baker Donelson

Powering Up Part 2: HHS Announced OCR Enforcement Authority for Part 2 Final Rule

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The Office for Civil Rights (OCR) will be ready to enforce the 2024 Part 2 Final Rule by the February 16, 2026, compliance deadline now that the U.S. Department of Health & Human Services (HHS) has delegated enforcement...more

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

Alston & Bird

OCR to Enforce Part 2 Provider Compliance for Patients’ Substance Use Disorder Records

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Our Health Care Group discusses a new role for the HHS Office for Civil Rights (OCR) in enforcing HIPAA Part 2 provider confidentiality rules for patients’ substance use disorder records....more

McGuireWoods LLP

Product Liability & Mass Tort Monitor: September 2025

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The Product Liability & Mass Tort Monitor is a monthly newsletter delivering critical updates, data insights and actionable strategies for navigating the complexities of product liability and mass tort litigation....more

Greenbaum, Rowe, Smith & Davis LLP

One Big Beautiful Bill Act: An Overview of Key Healthcare Provisions & Impacts

The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025. A sweeping piece of legislation that reshapes healthcare financing and delivery across Medicaid, Medicare, and the insurance marketplaces, the bill...more

Holland & Knight LLP

HHS Signals Enforcement Regarding Patients' Substance Use Disorder Treatment Records

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The U.S. Department of Health and Human Services (HHS) on Aug. 27, 2025, published a Statement of Delegation of Authority (Statement) in the Federal Register. HHS Secretary Robert F. Kennedy Jr. delegated authority to the HHS...more

Arnall Golden Gregory LLP

When Patients Leave Against Medical Advice: What Hospitals Miss and Why It Matters

Delivering high-quality healthcare becomes difficult when patients disregard their doctors’ advice. A patient who chooses to leave the hospital against medical advice (“AMA”) represents a particularly severe case of...more

Bradley Arant Boult Cummings LLP

Crank the Party Up: Is the DEA About to Get It On with Psilocybin?

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the...more

Alston & Bird

Health Care Week in Review | CMS Announces Oversight Initiative to Increase Medicaid and CHIP Citizenship Enforcement; HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

OIG Advisory Opinion 25-09: Careful and Intentional Structure Yields Positive Results for Physician-Owned Entity

The Proposed Arrangement - On August 7, 2025, the OIG issued Advisory Opinion 25-09.1 In this instance, the Requestor was a medical device developer, manufacturer, and seller of certain medical devices related to emergency...more

Sheppard Mullin Richter & Hampton LLP

Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions

I. Overview of Telehealth and Tele-Prescribing Landscape Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities...more

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...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

Amundsen Davis LLC

Federal Public Benefits and Immigration Status: What HHS’s Guidance Means for Mental Health Providers

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Mental health services are often partially funded with federal money, whether through grants or federal health care plans. Recently, the Department of Health and Human Services (“HHS”) updated its guidance clarifying how...more

Wiley Rein LLP

FDA’s Proposed Ranking Tool Gives Public Opinion a Seat at the Food Safety Table

Wiley Rein LLP on

With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

Paul Hastings LLP on

On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

DLA Piper

Paying for Direct Primary Care Arrangements With HSAs is Now Permitted – With Caveats

DLA Piper on

While proposed frequently in Congress over the past few years, the One Big Beautiful Bill Act (OBBBA) has succeeded in revising the rules governing health savings accounts (HSA) in key ways that allow them to be used to pay...more

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...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

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Foley & Lardner LLP

CMS Finalizes Rule Change Applying Preponderance of the Evidence Standard to Agent, Broker, and Web-Broker Exchange Agreement...

Foley & Lardner LLP on

In its recently issued Final Rule (CMS-9884-F; 90 FR 27074-01; the Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized revisions to 45 C.F.R. § 155.220(g)(2) to specify a standard of proof for...more

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Husch Blackwell LLP

Federal Court Vacates 2024 HIPAA Reproductive Health Privacy Rule: Key Impacts for Covered Entities and NPP Compliance

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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

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