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Conyers

Captive Insurance in Bermuda

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Bermuda is the world’s leading domicile for captive insurance companies, with over 600 active captive licences on its register generating over US$24 billion in gross written premium. Having formed the first modern captive in...more

Mintz

Congressional Democrats Press For Integration of Climate-Related Financial Risks in Insurance Regulation

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On August 12, 2024, three Congressional Democrats (Casten (D-IL); Waters (D-CA); and Senator Whitehouse (D-RI)) sent a letter to the National Association of Insurance Commissioners (NAIC), inquiring as to “the status of the...more

Orrick, Herrington & Sutcliffe LLP

RegFi Episode 43: Investing in Financial Inclusion

Kabir Kumar, director of policy and ecosystem building at Flourish Ventures, joins RegFi co-hosts Jerry Buckley and Sasha Leonhardt to explore the fundamental role of technology in expanding access to fair and stable...more

Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more

Goodwin

Acquiring or Investing in EU Crypto-Asset Businesses: Further Clarity on MiCA

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In our previous alert “Acquiring or Investing in EU Crypto-Asset Businesses: MiCA’s Impact,” we discussed the impact of the European Union (EU) Markets in Crypto-Assets Regulation (MiCA) on the acquisition or investment in EU...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

King & Spalding

EU Regulations Restricting Imports of Renewable Natural Gas and Green Hydrogen Derivative Products

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The European Commission (EC) is in the process of implementing its “Union database” (UDB) to track all renewable gases and liquid fuels. Gases and fuels, whether produced in the EU or imported, will need to be registered in...more

Clark Hill PLC

New York Department of Financial Services Proposes Circular to Address Insurance Companies’ Use of Artificial Intelligence

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On Jan. 17, the New York Department of Financial Services (“NYDFS” or “Department”) issued for public comment a proposed circular letter (“Circular”) for addressing the use of artificial intelligence systems (“AIS”) and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Patterson Belknap Webb & Tyler LLP

Implementation of DFS Cybersecurity Amendments Continues as Ransomware Attacks Dominate Headlines

Last month, as the New York State Department of Financial Services (“DFS”) began phasing in amended cybersecurity regulations and continued enforcement actions against noncompliant entities, a wave of ransomware attacks...more

Kidon IP

Response to the USPTO, The ITA, and NIST call for Public Comments on Standards, Part 2 of 7

Kidon IP on

On November 6, 2023 I submitted a response to the public comments which can be found here.  I have also included my comments in full on this blog in a series of posts including the below.  The only change in my submission is...more

Rothwell, Figg, Ernst & Manbeck, P.C.

White House AI Order Balances Innovation And Regulation

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more

Holland & Knight LLP

What to Know About the New Artificial Intelligence Executive Order

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President Joe Biden on Oct. 30, 2023, signed an expansive, 111-page Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (EO) in response to the administration's growing concerns...more

McGlinchey Stafford

Is THCA Legal? The State Line is the Bottom Line

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Tetrahydrocannabinolic acid (THCA) is one of the most misunderstood and controversial cannabinoids in the Cannabis sativa (cannabis) plant. While booming in popularity, THCA is also a high-risk cannabinoid from a legal...more

Kidon IP

Commentary and Concerns About the European Commission’s Proposed Regulation of SEP Licensing

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This Summer, the European Commission asked for comments on the proposed regulations that are wending their way through the European Parliament (see, e.g.), and I (here for mine) and some 150 other individual and entities...more

Ankura

Common PCAOB Inspection Findings and Actions Firms Can Take to Improve Audit Quality and Reduce the Risk of Regulatory Enforcement...

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In July 2023, the PCAOB published the spotlight, “Staff Update and Preview of 2022 Inspection Observations.” The article summarized the PCAOB's common findings from its 2022 inspection season. Many of the findings observed in...more

Dechert LLP

Tornado Watch: Popular Cryptocurrency Mixer “Tornado Cash” Dealt Two Major Blows in a Week

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Tornado Cash, a cryptocurrency mixer, recently suffered two major setbacks in federal regulatory efforts to block its use and prosecute its founders. First, a federal district court threw out a lawsuit challenging the...more

Womble Bond Dickinson

Buckle Up: Artificial Intelligence Accelerates Drug Discovery and Streamlines Patient Care

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The concept of artificial intelligence (AI) in drug discovery and manufacturing has been in progress for more than 10 years; however, with the current advancements in technology, medicine, and research, AI is closer than ever...more

Bradley Arant Boult Cummings LLP

How Smart Is Your Artificial Intelligence Policy?

There is a great YouTube video that has been circulating the internet for half a decade that reimagines a heuristically programmed algorithmic computer “HAL-9000” as Amazon Alexa in an iconic scene from “2001: A Space...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Thomas Fox - Compliance Evangelist

Messaging Compliance in a Shifting Regulatory Landscape: U.S. Regulatory Compliance

Are you ready to learn how to implement electronic communications capture and supervision in your firm for better compliance and prevention of regulatory violations? Is messaging compliance giving your compliance function...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Jenner & Block

PFAS in Consumer Products

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Developing a Proactive and Strategic Game Plan - Per- and polyfluoroalkyl substances (PFAS) in consumer products continue to be in the regulatory and litigation spotlight in 2023. Manufacturers and downstream businesses...more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

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Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Jenner & Block

Client Alert: PFAS in Consumer Products: Developing a Proactive and Strategic Game Plan

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Per- and polyfluoroalkyl substances (PFAS) in consumer products continue to be in the regulatory and litigation spotlight in 2023. Manufacturers and downstream businesses should be actively preparing to comply with the...more

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