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Risk Management Final Rules Compliance

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Blank Rome LLP

Cybersecurity in the Marine Transportation System: What You Need to Know About the Coast Guard's Final Rule

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The U.S. Coast Guard (“USCG”) published a final rule on January 17, 2025, addressing Cybersecurity in the Marine Transportation System (the “Final Rule”), which seeks to minimize cybersecurity related transportation security...more

Sheppard Mullin Richter & Hampton LLP

At Long Last – The FAR CUI Rule is Here! 

The wait is finally over! After more than 14 years of anticipation, the Federal Acquisition Regulation (“FAR”) Proposed Rule on Controlled Unclassified Information (“CUI”) was released on January 15, 2025 and comes as part of...more

Sheppard Mullin Richter & Hampton LLP

Data, Deals, and Diplomacy, Part III: DOJ Issues National Security Final Rule with New Data Compliance Obligations for...

On January 8, 2025, the Department of Justice (“DOJ”) published its final rule addressing Executive Order (E.O.) 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more

Proskauer - Health Care Law Brief

CMS Publishes Final Rule, Effective January 1, 2025, Addressing the Requirements for Reporting and Returning Overpayments

The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge”...more

Buchalter

Significant New HIPAA Obligations on Their Way for 2025

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The Department of Health & Human Services (HHS) issued proposed changes to the HIPAA Security Rule (“Proposed Rule”) on January 6, 2025, and is accepting comments from the public until March 7, 2025. The Proposed Rule...more

Perkins Coie

DOJ’s Final Rule on Data Transfers: Impacts Across Industries

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As of January 23, 2025, the regulation discussed below has not been withdrawn by the Trump administration and is not subject to automatic withdrawal under President Trump’s Executive Order freezing regulations. It currently...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

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The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

MG+M The Law Firm

EPA Argues PFAS Maximum Contaminant Levels Are Lawful and in Accordance With Statutory Procedure

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On April 10, 2024, the United States Environmental Protection Agency (EPA or Agency) promulgated the first-ever national, legally enforceable maximum contaminant levels (MCLs) for six per- and polyfluoroalkyl substances...more

Stoel Rives LLP

New 2025 EPA Risk Management Rules on TCE, PCE, and CTC

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The U.S. Environmental Protection Agency (“EPA”) recently enacted further restrictions for three chlorinated solvents – trichloroethylene (“TCE”), perchloroethylene (“PCE”) and carbon tetrachloride (“CTC”).  On December 17...more

Morrison & Foerster LLP

Open Banking Update: CFPB Recognizes First Open Banking Standard-Setting Body

On January 8, 2025, the Consumer Financial Protection Bureau (CFPB) issued a decision and order approving the application of Financial Data Exchange, Inc. (FDX) for recognition as a standard-setting body (SSB) under the...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

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In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

A&O Shearman

European Banking Authority finalizes guidelines on management of ESG risks

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The European Banking Authority has published its final guidelines on the management of ESG risks. The guidelines set out requirements for institutions for the identification, measurement, management, and monitoring of ESG...more

Bergeson & Campbell, P.C.

EPA Issues Final Risk Management Rules for Trichloroethylene, Perchloroethylene, and Carbon Tetrachloride

The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for trichloroethylene (TCE) and perchloroethylene (PCE) on December 9, 2024, and for carbon...more

Constangy, Brooks, Smith & Prophete, LLP

OSHA penalties increased for citations issued in 2025

Consistent with the 2015 Inflation Adjustment Act, which provides for the annual increase in penalties under the Occupational Safety and Health Act by the previous year’s rate of inflation, the maximum OSHA penalties for...more

Ropes & Gray LLP

DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern

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On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more

Blank Rome LLP

Three Major Features of the New Final Rule on Suspension and Debarment

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Introduction - On January 3, 2025, the Federal Acquisition Regulatory Council (“FAR Council”) published a long-awaited final rule to update suspension and debarment procedures. 90 Fed. Reg. 507. The final rule takes...more

King & Spalding

DOJ Issues Final Rule Restricting Foreign Access to U.S. Data

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The rule imposes substantial new diligence, reporting, cybersecurity, and auditing obligations on companies. On December 27, 2024, the U.S. Department of Justice (“DOJ”) issued a final rule implementing Executive Order...more

Goldberg Segalla

EPA Rule Kills Trichloroethylene and Cripples Perchloroethylene

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Our blog has written on EPA’s placement of Trichloroethylene (TCE on the chopping block and the phase down of Perchloroethylene (PCE). And early this week, the Environmental Protection Agency finalized those proposed rules...more

DarrowEverett LLP

The Heat Is On SEC’s Climate-Related Disclosure Rules

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On March 6, 2024, the U.S. Securities and Exchange Commission (the “SEC”) adopted new final rules requiring issuers to include extensive disclosure in registration statements and periodic reports regarding material...more

The Volkov Law Group

SEC Finally Issues Climate Change Disclosure Rules

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After months and months of deliberations and negotiations, the SEC finally issued its final rules for climate disclosures. The Enhancement and Standardization of Climate-Related Disclosures for Investor (“the final rule”)....more

Saul Ewing LLP

Public Companies Quarterly Update (Q1 2024)

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Welcome to Saul Ewing’s Public Companies Quarterly Update series. Our intent is to, on a quarterly basis, highlight important legal developments of which we think public companies should be aware. This edition is related to...more

ArentFox Schiff

EPA Finalizes Changes to the Clean Air Act’s Risk Management Program

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On March 1, the US Environmental Protection Agency (EPA) announced finalized amendments to the Clean Air Act’s Risk Management Program (RMP) through the Safer Communities by Chemical Accident Prevention Rule (Final Rule). ...more

King & Spalding

SEC Adopts Final Climate Disclosure Rules

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Proposed rules are moderately scaled-back in final version; Scope 1 and 2 are required if material; Scope 3 is out; compliance will still be burdensome - On March 6, 2024, by a split vote of 3-2, the U.S. Securities and...more

Latham & Watkins LLP

SEC Adopts Final Climate-Related Disclosure Rules

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On March 6, 2024, in a 3-2 vote, the US Securities and Exchange Commission (SEC) adopted final rules requiring registrants to disclose certain climate-related information in registration statements and annual reports. ...more

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