News & Analysis as of

Remedial Actions Compliance

Akin Gump Strauss Hauer & Feld LLP

“Under the Wire” E-Comms Settlements: More Confusion Than Closure

On January 13, 2025, the U.S. Securities and Exchange Commission announced settled enforcement actions with five registered investment advisers for failing to maintain and preserve internal electronic communications. These...more

Society of Corporate Compliance and Ethics...

The value of the close call

Much has been written about the importance of identifying lessons learned and taking remedial action in the aftermath of an investigation into compliance failures. But an equally valuable exercise can result from exploring...more

Gardner Law

FDA Issues Numerous Warning Letters

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The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Guidepost Solutions LLC

DOJ Maintains Interest in Bribery in Mexico and Latin America

Recent Department of Justice (“DOJ” or “Department”) activity on bribery in Mexico and Latin America sends a warning and provides a roadmap to companies doing business there.  By following the roadmap, companies may escape...more

Mintz

What we can learn from one of the most detailed ESG SEC actions to date

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The U.S. Securities & Exchange Commission (“SEC”) recently found that an investment adviser mischaracterized its integration of Environmental, Social, and Governance (“ESG”) factors into research and investment...more

Torres Trade Law, PLLC

OFAC and BIS Announce Microsoft Settlement of Sanctions and Export Control Violations

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On April 6, 2023, the Department of Treasury Office of Foreign Assets Control (“OFAC”) and the Department of Commerce Bureau of Industry and Security (“BIS”) announced a settlement with Microsoft Corporation (“Microsoft”) and...more

Husch Blackwell LLP

The Rules They Are A-Changin’: CMS Proposes a Significant Change to the 60-Day Repayment Rule

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The Centers for Medicare and Medicaid Services (CMS) unexpectedly proposed a rule change that could have a significant impact on how hospices investigate compliance issues and take remedial action. The rule change directly...more

Snell & Wilmer

Texas Finds Actual Notice is Not Substantial Compliance with a Written Notice Provision

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The Supreme Court of Texas recently addressed notice requirements in a construction contract. In James Construction Group, LLC v. Westlake Chemical Corporation, the court held that even though the substantial compliance...more

Thomas Fox - Compliance Evangelist

Cold, Fog and Root Cause Analysis

My heart and thoughts continue to go out to my fellow Houstonians and Texans affected by the cold snap of 2021. For those of us who thought 2021 might bring more sanity than 2020, we have experienced the first armed attacked...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Orlando, FL - January 29th, 8:25 am - 5:30 pm EST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

ArentFox Schiff

Justice Department Offers New Antitrust Guidance With Lessons for Nonprofits, Associations, and Other Member-Owned and Operated...

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When was the last time your organization reviewed its antitrust compliance program? The Antitrust Division of the US Department of Justice announced a new policy to incentivize corporate antitrust compliance programs, which...more

BCLP

FCA Defendants and Counsel Beware: New DOJ Guidance on FCA Cooperation Credit May Leave Too Much to Prosecutors’ Discretion

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In recent weeks, the United States Department of Justice (“DOJ”) published guidance in the Justice Manual at Section 4-4.112 on how it will award cooperation credit to entities and individuals that are being investigated for...more

Maynard Nexsen

Cooperation Credit in False Claims Act Defense and the Potential Impact of Reimbursement Analysis and Compliance

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While white collar and healthcare counsel have long known that one of the best strategies to reducing risk in defending a False Claims Act (FCA) case is cooperation and execution of compliance actions, the Department of...more

Bass, Berry & Sims PLC

Mixed Messages: DOJ Releases New FCA Cooperation Guidelines, while Study Questions Whether Cooperation Actually Garners Credit

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The U.S. Department of Justice (DOJ) routinely encourages the subjects of False Claims Act (FCA) enforcement actions to make voluntary disclosures and fully cooperate with the government on the premise that cooperation leads...more

Jones Day

DOJ Issues Guidance on Cooperation in FCA Cases

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The U.S. Department of Justice seeks to use the potential for a reduced penalty amount and damages to encourage self-disclosure of misconduct and cooperation during FCA investigations. On May 7, 2019, the U.S. Department...more

Mintz - Health Care Viewpoints

DOJ Issues Guidance on Cooperation Credit in FCA Settlements

The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously...more

Bradley Arant Boult Cummings LLP

DOJ Provides Guidelines for Reducing False Claims Act Settlements through Cooperation - Government Enforcement Update

This week, the Department of Justice (DOJ) formalized and expanded its guidance for how defendants can earn cooperation credit in False Claims Act (FCA) cases and thereby reduce settlement amounts. New section 4-4.112 of the...more

Dorsey & Whitney LLP

DOJ’s New FCPA Pilot Program: The Offer of Enhanced Credit

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DOJ’s continuing focus on individuals has spawned a new one year FCPA Pilot Program which offers companies enhanced cooperation credit The new Pilot Program is part of an overall effort to bolster FCPA compliance. Those...more

Holland & Knight LLP

Establishing an Effective Compliance Program: An Overview to Protecting Your Organization

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In This Issue: - Overview - Standards and Procedures - Organizational Leadership and Culture - Reasonable Efforts to Exclude Bad Actors From Managerial Ranks - Training and Education - Monitoring,...more

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