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Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Mayer Brown

Biden Administration Issues First-Ever National Security Memorandum on Artificial Intelligence

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On October 24, 2024, President Biden issued the first-ever National Security Memorandum (NSM) on artificial intelligence (AI), fulfilling another directive (subsection 4.8) set forth in the Administration’s Executive Order on...more

Nossaman LLP

FCC and CPPA Partner to Enhance Consumer Privacy and Data Safeguards

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The Federal Communications Commission’s (FCC) Privacy and Data Protection Task Force announced a Memorandum of Understanding (MOU) with the California Privacy Protection Agency (CPPA). FCC Chairwoman Jessica Rosenworcel...more

Foley & Lardner LLP

Medicare Overpayments: CMS Issues Final Regulations Implementing Changes to 60-day Refund Rule

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On Friday, November 1, 2024, the Center for Medicare & Medicaid Services (CMS) issued the display copy of the final rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare...more

Payne & Fears

Eyes on Sacramento: Year-End Legislative Updates

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With the California’s legislative session ending in October, we now know which bills made it through the legislative process and were presented to the governor, and which bills died along that path. For those bills that made...more

Sands Anderson PC

The Future of Fines under the Clery Act Post SEC v. Jarkesy

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This spring, the U.S. Department of Education imposed a staggering $14 million fine against Liberty University, a private university in Lynchburg, Virginia. The DOE fined Liberty for violating the federal Clery Act which...more

Foley & Lardner LLP

Reminder — Minimum Salary Requirements for Exempt Employees Increase on January 1, 2025

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As we wrote about earlier this year, the U.S. Department of Labor (DOL) finalized a rule on April 23, 2024, increasing the standard salary level for the “white collar” exemptions under the Fair Labor Standards Act (FLSA) at...more

Brownstein Hyatt Farber Schreck

CEQA News You Can Use - November 2024 - Volume 9, Issue 3

Welcome to “CEQA News You Can Use,” a quarterly production of Brownstein Hyatt Farber Schreck, LLP’s Natural Resources lawyers. This publication provides quick, useful bites of CEQA news, which we hope can be a resource to...more

Best Best & Krieger LLP

Federal Guidelines for the Responsible Acquisition of AI—What Local Governments Should Know

The Office of Management and Budget (“OMB”) recently issued a memorandum outlining new requirements for the responsible procurement of artificial intelligence (“AI”) capabilities by federal agencies. While the OMB’s guidance...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Goodwin

New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs

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On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more

Benesch

The Use of Mock DOT Audits

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A Department of Transportation (“DOT”) audit is something that all motor carriers dread. The potential for a Federal Motor Carrier Safety Administration (“FMCSA”) investigator can often have adverse consequences....more

Bradley Arant Boult Cummings LLP

ASBCA Deems Late-Asserted Jurisdictional Defense Forfeited

In Appeal of – JE Dunn Construction Co., the Armed Services Board of Contract Appeals considered and denied the government’s post-hearing motion to dismiss JE Dunn’s complaint for failure to submit sums certain for each of...more

Mayer Brown Free Writings + Perspectives

SEC Division of Examinations Announces 2025 Exam Priorities

On October 21, 2024, the Division of Examinations (“EXAMS” or the “Division”) of the U.S. Securities and Exchange Commission (“SEC”) released its examination priorities (the “2025 Priorities”) for fiscal year 2025 (which...more

Foley Hoag LLP - Cannabis and the Law

ALJ Hearing on Rescheduling Faces Delay Over Witness Standing

The U.S. Drug Enforcement Administration (DEA) is facing a minor delay in a crucial hearing initially scheduled for December 2, 2024, regarding the rescheduling of cannabis under federal law. Chief Administrative Law Judge...more

Sheppard Mullin Richter & Hampton LLP

CMS Continues to Plan AHEAD Amid Rising Healthcare Costs

On October 28, 2024, the Centers for Medicare & Medicaid Services (“CMS”) announced the latest states to participate in the voluntary state total cost of care (“TCOC”) model: the All-Payer Health Equity Approaches and...more

Thomas Fox - Compliance Evangelist

How the 2024 ECCP Changes Compliance Culture Expectations

This 2024 ECCP is groundbreaking for several reasons. Not only does it elevate the role of compliance culture, but it also requires companies to take measurable steps to ensure a strong compliance environment that permeates...more

Franczek P.C.

PAC Issues Binding Decision Regarding “Open and Convenient” Meeting Requirement

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The Illinois Public Access Counselor (PAC) issued its tenth binding opinion of the year, finding the Village of Dolton Board of Trustees violated the Open Meetings Act (OMA) by failing to make two Board meetings convenient...more

A&O Shearman

Federal Circuit Affirms PTAB Unpatentability Findings Regarding Network Security Patents

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On October 31, 2024, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion affirming the final written decisions of the Patent Trial and Appeal Board (“PTAB”) finding that two of Centripetal Network,...more

Ropes & Gray LLP

DOJ Issues Notice of Proposed Rulemaking to Restrict Flow of Bulk Sensitive Personal Data to China and other Countries of Concern

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On October 29, 2024, the Department of Justice (“DOJ”) published its Notice of Proposed Rulemaking (“NPRM”) to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data...more

Perkins Coie

FDA Human Foods Priority Deliverables for FY 2025

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On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025.  By way of brief background, FDA designed the HFP to...more

Schwabe, Williamson & Wyatt PC

Mid-America Milling v. DOT: Legal Implications for the Disadvantaged Business Enterprise ‎Program

In Mid-America Milling Company v. United States Department of Transportation, Case No. 3:23-cv-00072 (“Mid-America”), the plaintiffs challenged the United States Department of Transportation’s (“DOT”) use of a rebuttable...more

Balch & Bingham LLP

Sackett, One Year Later

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After last year’s Supreme Court's decision in Sackett v. Environmental Protection Agency, there remains confusion regarding how the ruling affects economic development projects such as residential and commercial building,...more

McDermott Will & Emery

Weekly IRS Roundup October 28 – November 1, 2024

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Check out our summary of significant Internal Revenue Service (IRS) guidance and relevant tax matters for the week of October 28, 2024 – November 1, 2024....more

Erise IP

Eye on IPRs, October 2024: USPTO Issues Final PTAB Procedure Rules

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Every month, Erise’s patent attorneys review the latest inter partes review cases and news to bring you the stories that you should know about: USPTO Issues Final Rules on PTAB Procedure - The U.S. Patent and...more

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