Risk-Based Approaches

News & Analysis as of

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

Verifying Anti-Corruption Programs – Insights from TI-USA

Has your company implemented a program to prevent, deter and detect corruption? If so, have you verified it to ensure it is effective and appropriate for the level of risk faced by your company? Verification of...more

Sprint Agrees to Pay FTC $2.95 Million to Settle Risk-Based Pricing Rule Charges Under the FCRA

Mobile service providers frequently look at their customers’ credit reports and scores to determine the best pricing plans for those customers. But asa recent settlement between Sprint Corporation and the Federal Trade...more

FinCEN Proposes Anti-Money Laundering and Suspicious Reporting Rules for Registered Investment Advisers

On August 25, 2015, the US Treasury Department’s Financial Crimes Enforcement Network (FinCEN) proposed rules that would require registered investment advisers to adopt anti-money laundering (AML) programs and report...more

Common FCPA Issues

As our previous posts illustrate, violations of the Foreign Corrupt Practices Act (“FCPA”) can carry a hefty cost. Two issues are commonly the impetus for FCPA violations and, practically speaking, pose significant FCPA...more

Tips for Going Global: Plan Before You Expand

Companies enjoying success in the U.S. often seek global expansion to gain strategic benefits from accessing new markets—new revenue potential, talent acquisition and increased brand awareness. Before replicating your...more

Joint Committee of ESAs Consults on Risk-Based Supervision and Risk Factors Guidelines

On October 21, 2015, the Joint Committee of the European Securities and Markets Authority, the European Banking Authority and the European Insurance and Occupational Pensions Authority (together, the European Supervisory...more

FTC Announces Proposed Settlement with Telecommunications Company for Alleged FCRA Violations

On October 21, the FTC announced a $2.95 million settlement with a telecommunications company for alleged violations of the FCRA. According to the FTC, the company violated the FCRA’s Risk-Based Pricing Rule by failing to...more

BCBS October 2015 Progress Report on Implementation of Basel Regulatory Framework

On October 15, 2015, BCBS issued its ninth progress report (BCBS 338) on BCBS members’ implementation of Basel II, Basel 2.5 and Basel III, as at the end of September 2015. The report focuses on the status of domestic...more

NAIC Proposes Changes to Life Insurer Disclosure Requirements and Treatment of Investment Affiliates

This month, the NAIC set forth a variety of proposals relating to changes risk-based capital (“RBC”) requirements, as well as treatment of investment affiliates. In particular, the NAIC seeks to require life insurers to...more

Basel Committee updates on priorities

Stefan Ingves has spoken on the Basel Committee’s priorities for the next year. He focused on: - finalising the post-crisis regulatory reforms: he looked particularly at the framework now in place for liquidity, leverage...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Telehealth and Consumer Subscription Models

Telehealth opportunities continue to grow at an exponential rate, aligning with the concurrent growth of retail and consumer-focused medicine. Capturing the retail sentiment, companies are looking to offer subscription-based...more

Recent Changes & Developments Regarding US Department of Defense Foreign Ownership, Control or Influence Mitigation

The Defense Security Service (DSS) has recently undergone several notable staffing changes and announced procedural developments relevant to companies under foreign ownership, control, or influence (FOCI). DSS is the...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

FDA Releases Two Final Food Safety Rules: What You Need to Know

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more

Financial Services Weekly News - September 2015 #3

Regulatory Developments: CFTC Grants Temporary Registration as SEF to LedgerX Bitcoin Options Exchange and Clearing House - On Sept. 10 the CFTC announced that it had issued an Order of Temporary Registration as a...more

NAIC Summer 2015 National Meeting (A)XXX Developments and Key Takeaways

A number of important developments in the regulation of (A)XXX reserve financing transactions ((A)XXX transactions) emerged during the NAIC Summer 2015 National Meeting (Summer Meeting). Our roadmap through the NAIC’s...more

Risky Business: Assessment of Inherent Risks of Money Laundering and Terrorist Financing in Canada and Guidance on the Risk-Based...

In preparation for the audit of Canada’s anti-money laundering and terrorist financing regime by the Financial Action Task Force (FATF) in the fall of 2015, the Department of Finance and the Financial Transactions and Reports...more

The Imperative for Data-Driven Compliance: Provide Your Organization with an Affirmative Defense with Useful Data

When I think of compliance data, the first thing that comes to mind is defense. If you don’t know if or how well your compliance initiatives are working, you’ll be hard pressed to defend or improve your program. However, a...more

Corrective Actions: When Corruption Happens on Your Watch

As news stories, case studies, academic literature and enforcement actions illustrate, a company can have a robust anti-corruption program in place, yet can face investigations and possible liability for the corrupt actions...more

Your Questions: Let’s Talk Risk - A Q&A Session about How to Achieve a Risk-based Approach to Compliance Management

Risk is at the heart of every compliance program. But that’s sometimes easier said than done. In January 2015, Kwamina Williford, Partner at Holland & Knight; Chris Caron, Compliance Director at Kiewit; and Joe LeBas of...more

Four Compliance Metrics That Need to Die: Empty Metrics that Aren’t Worth Tracking or Reporting

I’m continuously struck by the compliance industry’s challenges around program measurement and reporting. Most recently, it was the annual Compliance Trends Survey from Compliance Week and Deloitte that delivered the bad...more

Assessing Your Approach To Compliance Risk Management: Compliance Programs Should Be Risk-Based — Here's How You Get There

Risk assessments are one of the first steps on the path to an effective risk-based compliance program, but it’s how you continue to manage and mitigate risk that truly determines if your program is successful. Kwamina...more

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