News & Analysis as of

Policies and Procedures Enforcement Actions Compliance

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

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Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Lowenstein Sandler LLP

The Importance of Complying with Private Fund Documents for Affiliate Transactions

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Private fund advisers continually balance their ongoing responsibility to ensure that the funds they advise comply with such funds’ governing documents and their responsibility to ensure their own compliance with applicable...more

Thomas Fox - Compliance Evangelist

FCPA Compliance Report: Stay the Course: Ellen Lafferty on Navigating Anti-Corruption Compliance in 2025

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast in compliance. Today, Tom Fox welcomes Ellen Lafferty, a well-known figure in the compliance community with a distinguished career in both...more

K2 Integrity

So You Received A Consent Order—How To Effectively Remediate Compliance Gaps

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A swift and effective response to a consent order is critical to demonstrating your firm’s commitment to complying with regulatory standards. Building a team that ensures all relevant stakeholders are involved and informed,...more

Saul Ewing LLP

OCR Imposes $200,000 Civil Money Penalty Against HIPAA-Covered Entity

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On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more

NAVEX

The Increasing Importance – and Visibility – of Internal Investigations 

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New DOJ whistleblower incentives. Investigation-related KPIs. Accountability demands from stakeholders of all stripes.    A combination of hard work by ethics and compliance professionals, high profile internal system...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Venable LLP

Is Your Company's Overseas Bribery Prevention Program Still Necessary Under Trump's DOJ?

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A recent executive order (EO) and Department of Justice (DOJ) policy statement issued in the first weeks of February signal a potentially dramatic shift in the DOJ's approach to enforcing the Foreign Corrupt Practices Act...more

Foley & Lardner LLP

Top Tips for Companies to Prepare for an Immigration Visit

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Here are our top tips to assist companies and institutions in preparing for visits by immigration officials. The second Trump administration has set robust enforcement of the immigration laws as a top-level priority. On...more

Seward & Kissel LLP

SEC Charges Investment Adviser with Compliance Policy Failures Regarding its Handling of Material Nonpublic Information

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Who may be interested: Registered Investment Companies; Registered Investment Advisers; Compliance Officers - Quick Take: The SEC charged a hedge fund manager registered as an investment adviser (Adviser) with failing to...more

WilmerHale

SEC Enforcement Actions Reflect Expanding Focus on Advisers’ Policies and Procedures to Prevent Misuse of Material Nonpublic...

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The Securities and Exchange Commission (SEC) recently brought settled enforcement actions against two registered investment advisers for failing to establish, maintain, and enforce written policies and procedures reasonably...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Proskauer Rose LLP

SEC Enforcement Action Underscores Need for MNPI Policies in CLO Trading

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In a significant enforcement action, the SEC sanctioned a private fund manager for failing to establish and maintain adequate policies and procedures to prevent the misuse of material nonpublic information (MNPI) while...more

WilmerHale

SEC Sanctions CLO Manager for Inadequate Polices to Prevent Nonpublic Information Misuse

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On August 26, 2024, the Securities and Exchange Commission (SEC) announced an order against a registered investment adviser, Sound Point Capital Management, LP, for its failure to “establish, maintain, and enforce written...more

Goodwin

Supervisory Experience and Enforcement Actions Continue to Drive Supervisory Priorities and Policy Development

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This article identifies themes we have observed in recent public formal enforcement actions issued to institutions by the US federal bank regulatory agencies (Agencies) — the Board of Governors of the Federal Reserve System...more

Royer Cooper Cohen Braunfeld LLC

How Tailored Are Your Policies and Procedures? It Matters.

The SEC recently took action against Gainvest Legal Corp. and its owner. This action serves as a stark reminder for others in the financial services industry about the importance of a custom-tailored compliance program and...more

Health Care Compliance Association (HCCA)

Overlapping surgeries: Time for a compliance checkup?

Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...more

Health Care Compliance Association (HCCA)

An inside view of HIPAA enforcement

While many healthcare providers are generally aware of their obligations under HIPAA, most do not have a clear sense of what happens if they fail to meet these obligations. At best, most probably are familiar with headlines...more

BCLP

Regulators Impose Extraordinary Fine Amounts in Recent Off-Channel Communications Enforcement Actions

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The Securities and Exchange Commission (“SEC”) and the Financial Industry Regulatory Authority (“FINRA”) have, in two separate recent settled enforcement actions involving off-channel communications (“OCC”), imposed fine...more

K&L Gates LLP

The SEC Fines Stand-Alone Adviser for Off-Channel Communications

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Overview - On 3 April 2024, the US Securities and Exchange Commission (the SEC) announced the first settlement with a stand-alone registered investment adviser for, among other things, failures to maintain and preserve...more

Skadden, Arps, Slate, Meagher & Flom LLP

Understanding SEC’s Focus Amid Lack of Final AI Rules

Last year, the U.S. Securities and Exchange Commission (SEC) proposed ambitious rules relating to artificial intelligence (AI) that have drawn significant commentary and criticism. While it is unlikely that any changes in the...more

Holland & Knight LLP

Will Mariner Finance Decision Lead State Regulators to Bring CFPA Claims?

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A lengthy decision recently issued by the U.S. District Court for the Eastern District of Pennsylvania, Pennsylvania by Shapiro v. Mariner Fin., LLC, No. CV 22-3253, 2024 WL 169654 (E.D. Pa. Jan. 12, 2024) (Hodge, J.), may...more

NAVEX

How to Meet the Letter, Spirit and Intent of the DOJ’s Evolving Compliance Program Expectations

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With any new administration, the U.S. Department of Justice (DOJ) often shifts focus from one set of enforcement priorities to another. However, one area has remained a focus from administration to administration: guidance...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - May 6th - 9th, San Antonio, TX

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

American Conference Institute (ACI)

[Event] Mexico Summit on Anti-Corruption & Compliance Program - March 13th - 14th, Mexico City, Mexico

ACI’s Mexico Summit on Anti-Corruption & Compliance Programs returns on March 13-14, 2024 in Mexico City! Given the uncertainty with the looming Presidential election, as well as increased U.S. enforcement focus on Mexico...more

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