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Regulatory Requirements Department of Justice (DOJ) Department of Health and Human Services (HHS)

Latham & Watkins LLP

Week 15 in Review: Immigration, Tariffs, and Civil Rights

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The Trump administration continued its focus on immigration and indicated progress in trade talks as this week marked the end of its first 100 days....more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Holland & Knight LLP

Holland & Knight Health Dose: April 2, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

Baker Donelson on

The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

K&L Gates LLP

First Circuit Adopts But-For Causation Standard for Kickback-Premised False Claims Act Actions

K&L Gates LLP on

On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more

Polsinelli

Back to Backlog? Polsinelli Shareholders Share Insight on how Terminations of DAB Attorneys and Potential Removal of...

Polsinelli on

As the new administration continues its efforts to contract and streamline the federal government, recent developments at the U.S. Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) hint at...more

Latham & Watkins LLP

Week 6 in Review: Tracking Moves on Healthcare, National Security, Government Contracts, and DEI

Latham & Watkins LLP on

The administration also turned its focus to copper imports, bird flu, and a proposed new path to American citizenship....more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

Holland & Knight LLP on

Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

Bass, Berry & Sims PLC on

As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

Mayer Brown on

Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

McDermott+

Special Report - No Surprises Act Update: The TMA III Decision - August 2023

McDermott+ on

The Texas Medical Association and additional plaintiffs have brought four Administrative Procedure Act (APA) challenges to the rules and guidance implementing the No Surprises Act (NSA) (termed TMA I, II, III and IV). The...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Mintz - Health Care Viewpoints

EnforceMintz — Significant 2022 Regulatory and Policy Developments

From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 27th, Lake Buena Vista, FL

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Virtual Event] Richmond Regional Healthcare Compliance Conference - December 9th, 8:25 am - 4:30 pm EST

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

Health Care Compliance Association (HCCA)

Telehealth regulatory oversight and enforcement trends

CT magazine (July 2022) - One of the notable impacts of the COVID-19 pandemic on the healthcare industry has been the boom in services provided via telehealth. This boom is in part due to temporary flexibilities applied...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Bradley Arant Boult Cummings LLP

DEA to Review Applications to Become Registered Marijuana Growers - Cannabis Industry News Alert

The average American consumer has probably noticed an increase in products for sale that include cannabidiol (CBD), a non-psychoactive component of cannabis. These products have seen an exponential increase in popularity,...more

Mintz - Health Care Viewpoints

DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation

Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...more

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