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Regulatory Oversight Compliance Regulatory Requirements

White & Case LLP

AI Watch: Global regulatory tracker - Brazil (UPDATED)

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Brazil intends to regulate AI through Bill No. 2,338/2023 ("Brazil's Proposed AI Regulation"), although there are currently no specific codified laws, statutory rules or regulations in Brazil that directly regulate AI....more

Foodman CPAs & Advisors

The Compliance Gap in AML AI: Why Audit-Ready Tools Matter

icraAs artificial intelligence reshapes financial compliance practices, regulators across Latin America and globally are increasing their scrutiny of AI-based AML tools. This article explores the growing audit gap, and what...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Conyers

Understanding Outsourcing Obligations for Cayman Islands Funds

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It has been two years since the Cayman Islands Monetary Authority (CIMA) introduced its Rule on Corporate Governance for Regulated Entities (the “Corporate Governance Rule”), and a year and a half since it came into force....more

Alston & Bird

5 Things to Think About When Using AI

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What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

Ropes & Gray LLP

Five Takeaways From the EU Commission’s AI Literacy Q&As

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Earlier this month, the European Commission released AI Literacy – Questions & Answers. The Q&As are a useful primer — both for organisations at the start of their literacy journey and those that, having taken steps to...more

White & Case LLP

AI Watch: Global regulatory tracker - OECD

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The OECD's AI recommendations encourage Member States to uphold principles of trustworthy AI. Status of the AI Regulations - The Adherents have agreed to promote, implement, and adhere to the Recommendation. The Principles...more

Davis Wright Tremaine LLP

CFTC Divisions Issue Staff Advisory on Referrals to Division of Enforcement

On April 17, 2025, the Market Participants Division, the Division of Clearing and Risk, and the Division of Market Oversight (collectively, the "Operating Divisions") of the CFTC, along with the Division of Enforcement...more

A&O Shearman

SRB consultation on expectations on valuation capabilities

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The Single Resolution Board (SRB) has published a press release confirming it had launched a public consultation on its expectations on valuation capabilities (dated 1 April). The consultation forms part of the Single...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

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In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

A&O Shearman

RTS on criteria for the composition of joint examination teams under EU DORA published in OJ

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Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more

Walkers

The BMA invites proposals to test Embedded Supervision in DeFi

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The Bermuda Monetary Authority ("BMA") has issued an invite for proposals from voluntary participants to take part in a pilot project aimed at testing Embedded Supervision practices within the context of DeFi. Embedded...more

Flaster Greenberg PC

SEC Offers Updated Guidance for Rule 506(c) Private Placements

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On March 12, 2025, the SEC published a No-Action Letter clarifying accredited investor verification requirements under Rule 506(c)....more

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Chambliss, Bahner & Stophel, P.C.

How To Get a Disabled Parking Permit

Disabled parking permits enable individuals with mobility issues to access businesses and public spaces more easily. Different types of disabled parking permits include permanent and temporary placards, license plates,...more

Cadwalader, Wickersham & Taft LLP

Regulation in Flux, March 2025 - CFTC Staff Withdraws Advisory on Swap Execution Facility Registration Requirement

On March 13, 2025, the Commodities Futures Trading Commission (“CFTC”) issued Letter 25-05, withdrawing controversial and much-criticized Staff Letter 21-19 (“SEF Registration Advisory”), which was issued September 29, 2021...more

Mayer Brown Free Writings + Perspectives

The SEC’s Staff of the Division of Corporation Finance Clarifies Its Views on Crypto Mining

On March 20, 2025, the SEC’s Staff of the Division of Corporation Finance (the “Division”) issued a statement providing its views that crypto mining activities (as defined in its statement) do not involve the offer and sale...more

Ropes & Gray LLP

New York Department of Health Issues Guidance Clarifying the Scope of its Health Care Transaction Law

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This month, nearly two years after the passage of New York’s health care transaction law, N.Y. Pub. Health Law § 4550 et seq. (described in our previous Alert), the New York State Department of Health (“DOH”) released...more

Husch Blackwell LLP

Deadline Ahead: NYDFS Compliance Notifications are due by April 15

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Businesses that are subject to the NYDFS Cybersecurity Regulations have four weeks left to submit their annual notices of compliance or acknowledge their noncompliance. When the regulations were amended in 2023, several of...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more

Cadwalader, Wickersham & Taft LLP

Amid Chaos, Regulatory Change Continues Apace, March 2025 - New CFTC Enforcement Guidance

On February 25th, 2025, the Commodity Futures Trading Commission’s (“CFTC”) Division of Enforcement (“Division”) issued a long-awaited advisory (the “Advisory”) regarding its evaluation of how a company’s or individual’s...more

A&O Shearman

ESMA guidelines on reverse solicitation under MiCAR

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The European Securities and Markets Authority (ESMA) has published official translations of its guidelines on situations in which a third-country firm is deemed to solicit clients established or situated in the EU and...more

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Foley & Lardner LLP

California: AB 1415 and Expanded OHCA Oversight — What Providers, MSOs, and Investors Need to Know

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On February 21, 2025, California introduced AB 1415, a bill aimed at expanding the regulatory oversight of the Office of Health Care Affordability (OHCA). As discussed in our previous blog, certain health care entities are...more

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