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Skadden, Arps, Slate, Meagher & Flom LLP

SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation

Introducing “SkadBytes,” our newest podcast where Skadden’s IP and Tech team discusses pivotal changes driving tech regulation and innovation. Host Deborah Kirk and colleagues Alistair Ho and Jonathan Stephenson reflect on...more

DLA Piper

Ireland: NIS2 Revamps Ireland’s Cybersecurity Landscape: Old Regulators, New Powers

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The NIS2 Directive has significantly reshaped the cybersecurity landscape across the EU. Since the implementation deadline in October 2024, EU Member States have been working to incorporate new standards into their national...more

Husch Blackwell LLP

New Exemption Order Creates More Flexibility and More Considerations with the Customer Identification Program Rule

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By an exemption order dated June 27, 2025, federal prudential regulators have given banks and credit unions some welcomed flexibility when collecting an individual’s or entity’s taxpayer identification number (TIN) during...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

Littler on

The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Transportation/Hazardous Materials: Pipeline and Hazardous Materials Safety Administration Interpretive Letter Addressing...

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in a June 5th interpretive letter the application of the Hazardous Materials Regulations (“HMR”) applicable to reclassifying a...more

Walkers

ESMA principles on third-party risk supervision

Walkers on

On 12 June 2025, ESMA published its principles on third-party risk supervision which are designed to assist supervisory authorities to identify, assess and supervise the third-party risks of EU entities operating across the...more

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

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The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

Hogan Lovells

MDCG published new guidance on the interplay between the MDR & IVDR and the AI Act

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On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Morgan Lewis - Tech & Sourcing

NIST Releases Updated Incident Response Guidance Under Its Cybersecurity Framework

During the Biden administration, there was a push to prioritize and modernize cybersecurity responses, and the National Institute of Standards and Technology (NIST) agreed to work with the technology industry to develop a new...more

NAVEX

AI Literacy: A Compliance Need and a Training Necessity

NAVEX on

The European Union recently published guidance on the training that companies should provide to employees to achieve “AI literacy” required under the EU AI Act – and like so much else about artificial intelligence these days,...more

Jackson Lewis P.C.

New DOL/EBSA Opinion Letter Program Offers A Path to Clarity for Plan Sponsors

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On June 2, 2025, the U.S. Department of Labor (DOL) announced a significant expansion of its compliance assistance tools by launching an Opinion Letter Program across five key enforcement agencies, including the Employee...more

Seyfarth Shaw LLP

New York Releases FAQs, Model Training, and Model Policy for Retail Workplace Violence Prevention Law

Seyfarth Shaw LLP on

A workplace violence prevention law passed by the New York State legislature in June 2024, signed into law by the Governor in September 2024, and amended in February 2025 is set to take effect in part on June 2, 2025. On May...more

A&O Shearman

CMORG AI Taskforce releases comprehensive AI Baseline Guidance

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The Cross Market Operational Resilience Group's (CMORG) AI Taskforce has released its AI Baseline Guidance Review (dated January 2025), accompanied by a press release. The CMORG AI Taskforce conducted a baseline review of...more

BCLP

HK Releases Guideline Concerning Generative AI

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On 15 April 2025, the Hong Kong Government’s Digital Policy Office published the Hong Kong Generative Artificial Intelligence Technical and Application Guideline (“Guideline”), which aims to provide operational guidance for...more

McGuireWoods LLP

Banks May Provide Cryptocurrency Transaction and Custody Services, but OCC Has Yet to Provide Clear Compliance Requirements

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On May 7, 2025, the Office of the Comptroller of the Currency (“OCC”) issued a follow up to its July 2020 Interpretative Letter 1170, which allowed national banks to provide cryptocurrency custody services to their customers....more

Jones Day

OMB Directs Agencies to Accelerate AI Adoption and Devise Governance Strategy

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The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....more

DLA Piper

Hong Kong released GenAI Technical and Application Guideline

DLA Piper on

On 15 April 2025, the Digital Policy Office (DPO) of the Hong Kong Government published the Hong Kong Generative Artificial Intelligence Technical and Application Guideline (Guideline), seeking to encourage stakeholders in...more

Morrison & Foerster LLP

CFTC Advisory Outlines Materiality Criteria for Enforcement Referrals

On April 17, 2025, three operating divisions (the “Operating Divisions”) of the U.S. Commodity Futures Trading Commission (“CFTC”) and the Division of Enforcement (“DOE”) provided guidance in CFTC Letter 25-13 (the...more

BakerHostetler

CFTC Provides Clarifying Guidance on Material Violations Regarding Self-Reporting, Cooperation, and Remediation System

BakerHostetler on

As we previously reported, in February, the CFTC’s DOE issued an enforcement advisory (the DOE Advisory) to provide guidance to market participants on how the DOE will evaluate a company’s or an individual’s conduct in the...more

Ballard Spahr LLP

OCC, FDIC eliminating ‘reputational risk’ from supervision, examinations

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The OCC has removed “reputational risk” from its handbooks and guidance and the FDIC is moving to do the same. ...more

Husch Blackwell LLP

CFTC Releases Criteria for Operating Divisions to Refer Violations to Enforcement Division

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On April 17, 2025, the Commodity Futures Trading Commission’s (CFTC) Market Participants Division (MPD), the Division of Clearing and Risk (DCR), and the Division of Market Oversight (DMO)—collectively the Operating...more

Hogan Lovells

Staying antitrust compliant: New BAFA guidance on sector initiatives in supply chain due diligence

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Supply chain due diligence has firmly taken root in the global regulatory landscape, setting clear compliance expectations on how companies should identify, assess, and address human rights and environmental risks across...more

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