News & Analysis as of

Risk-Based Approaches

Obtaining FDA clearance or approval of digital health products

by Hogan Lovells on

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more

Holmes, Innovation & Compliance: Part IV – Interpreting Data

by Thomas Fox on

I continue to explore the intersection of Sherlock Holmes, innovation and compliance by starting today with the story The Adventure of Silver Blaze....more

April 15 Isn’t Just Tax Day—It’s Also AML Certification Compliance Day

It’s not just your taxes that are due each year on April 15. For financial institutions, this coming April 15 is the date the New York Department of Financial Services’ (NYDFS’s ) new Anti-Money Laundering (AML) Part 504...more

Investment Services Regulatory Update - February 2018

by Vedder Price on

New Rules, Proposed Rules, Guidance and Alerts – SEC STAFF GUIDANCE AND ALERTS - SEC Staff Issues Guidance on Cryptocurrency-related Holdings - On January 18, 2018, the staff of the SEC’s Division of Investment...more

New FinCEN beneficial ownership requirements for legal entity customers to become effective in May 2018

by Thompson Coburn LLP on

Effective May 11, 2018, new Financial Crimes Enforcement Network (FinCEN) regulations (codified at 31 C.F.R. §§ 1010.230 and 1020.210(b)(5)) (the “New Regulations”) require that covered financial institutions, including...more

What Level of Due Diligence Should You Perform

by Thomas Fox on

Today, I want to take a deep dive and exploration of the levels of due diligence. Due diligence is generally recognized in three levels: Level I, Level II and Level III. Each level is appropriate for a different level of...more

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

Yakety Yak – Talk Back: Regulators Respond to HVCRE Complaints

by Dechert LLP on

On September 27, 2017, the Federal Reserve, FDIC and OCC released a Notice of Proposed Rulemaking (NPR) that they describe as simplifying compliance with certain aspects of the agencies’ risk based capital (RBC) rules to,...more

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Insurers to benefit from mutual solvency recognition between Mainland China and Hong Kong

by Hogan Lovells on

On 16 May 2017 the CIRC and the Hong Kong Office of the Commissioner of Insurance (“OCI“) entered into a framework agreement aimed at mutual recognition of solvency regimes between Mainland China and Hong Kong....more

The future of Hong Kong's insurance industry – New focus on reinsurance and captives?

by Hogan Lovells on

The Hong Kong Financial Services Development Council, an advisory body to the government, has recently released a report on the Hong Kong insurance sector. Its key recommendations are...more

Insuring and reinsuring Canadian risks from the United States

by Dentons on

Over the past ten years, regulation in Canada of insurers has evolved significantly. Prior to the financial crisis, Canada’s primary regulator had begun to move from a "rules-based" approach to regulation to a...more

Risk in Compliance Week: Part V – So What?

by Thomas Fox on

This week I have devoted my blog posts to thinking about the management of risk by considering the tools of forecasting, risk assessment and risk-based monitoring. I have been assisted on this journey by Ben Locwin, Director...more

Risk in Compliance-Part III, Risk-Based Monitoring

by Thomas Fox on

Today I continue my exploration of risk in compliance by starting a consideration of risk-based monitoring. As I have the previous two days, I honor a television star who died last week and today it is Mike Connors. While...more

ISO 37001: Why Your Anti-Corruption Policy Needs to Go Global

by Michael Volkov on

Ten years ago the standard anticorruption policy was nearly exclusively FCPA-focused. DOJ and SEC enforcement actions were the primary, if not the only, concern for corporate executives and board members. The UK Bribery Act...more

Excalibur Reinsurance Corporation Placed Into Liquidation

by Carlton Fields on

Excalibur had been in run-off status since 2003, and under regulatory supervision since at least 2013. A Pennsylvania court has now placed Excalibur into liquidation based on three grounds: (1) insolvency – Excalibur’s...more

FCA thematic review finds failures in oversight of authorised representatives in insurance industry

by DLA Piper on

On 22 July 2016, the Financial Conduct Authority (FCA) published the results of a thematic review in which the FCA found significant shortcomings in the control and oversight of appointed representatives (ARs) by their...more

President Obama Signs the Toxic Substances Control Act Modernization Act

Since its passage in 1976, TSCA has been widely criticized—by industry and environmental groups alike—for its perceived inefficacy. When first passed, TSCA aimed to fill an important gap in the nation’s environmental laws,...more

The Federal Reserve Board’s ANPR with Respect to Capital Requirements for Supervised Institutions Significantly Engaged in...

On June 3, 2016, the Board of Governors of the Federal Reserve System (FRB), approved an advance notice of proposed rulemaking (ANPR) regarding two potential regulatory capital frameworks for institutions under the FRB’s...more

Anti–Money Laundering Alert: FinCEN Finalizes Beneficial Ownership and Customer Due Diligence Requirements

by WilmerHale on

The Financial Crimes Enforcement Network (FinCEN) on May 11 released its long-awaited Final Rule (CDD Rule) that will require certain financial institutions to “look through” the nominal account holder to identify the...more

The Federal Reserve Board Outlines Approach For Capital Rules For Federally Supervised Insurance Groups

At the NAIC’s tenth International Insurance Forum, Daniel K. Tarullo, a member of the Board of Governors of the Federal Reserve System (FRB), outlined the FRB’s plans for: - ..the capital and liquidity rules for...more

Europe Is Shifting, And It’s a Big Deal – The New GDPR

by Seyfarth Shaw LLP on

The clock is now ticking. On May 4th the European Parliament published the final text of the General Data Protection Regulation (“GDPR”), and the rules of the game have significantly changed – at least in the context of EU...more

New Encryption Guidance Published by the ICO

by Reed Smith on

The UK Information Commissioner’s Office (ICO) has released updated guidance on the use of encryption. The guidance highlights that in many areas, the ICO expects encryption software to be used, and in the future where data...more

US Board of Governors of the Federal Reserve System Proposes Technical Amendments to Risk-Based Capital Surcharge for Global...

by Shearman & Sterling LLP on

The US Board of Governors of the Federal Reserve System proposed technical amendments to its rule requiring a risk-based capital surcharge for global systemically important bank holding companies. The rule, finalized by the...more

BCBS Reports on Regulatory Consistency of Risk-Weighted Assets for Credit Risk in the Banking Book

On April 1, the Basel Committee on Banking Supervision (“BCBS”) issued its second report: an analysis of risk-weighted assets (“RWA”) for credit risk in the banking book. The report’s first objective is to identify the main...more

65 Results
View per page
Page: of 3

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.