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Manatt, Phelps & Phillips, LLP

CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation...more

Bilzin Sumberg

Space Junk: What Goes Up, Must Come Down (Safely)

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Here in South Florida, we are used to strange stories. One example from this year: a “Florida Man” made a claim against NASA because a battery pack from the International Space Station crashed into his house on March 8, 2024....more

Robinson+Cole Data Privacy + Security Insider

California Privacy Protection Agency Announces Investigative Sweep of Data Brokers’ Compliance with Registration Requirements

Last week, the California Privacy Protection Agency (CPPA) announced it will conduct a public investigative sweep of data broker registration compliance under the California Delete Act....more

Robinson+Cole Data Privacy + Security Insider

Columbus, Ohio Notifies 500,000 of Data Breach from Ransomware Attack

The city of Columbus, Ohio, announced on May 29, 2024, that it was forced to take its systems offline due to a ransomware attack. According to its notice, the attack was perpetrated by “an established, sophisticated threat...more

Robinson+Cole Data Privacy + Security Insider

The Impact of Stolen Credentials

This week, Schneider Electric confirmed that it is investigating a security incident involving its JIRA internal development platform. The attacker group, “Grep,” allege that it stole 40 GB of data from the JIRA platform by...more

Womble Bond Dickinson

New Cyber Security Rules for US Technology Companies Operating in the EU

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The EU is in the course of passing a range of new cyber security legislation which will apply to US businesses who provide services in the EU. ...more

Robinson+Cole Data Privacy + Security Insider

Ex-Yahoo! Patents Asserted Against Fashion Retainer Shein

In the early to mid-2000s, Yahoo! worked to develop and refine its search engine capabilities.  During this period, Yahoo! obtained U.S. Patent Nos. 8,341,157, 7,698,329, 8,209,317, 9,805,097, and 8,527,623, which are...more

Robinson+Cole Data Privacy + Security Insider

Precious-Metal Refiner Hit with Data Breach Class Action over 2023 Cyber-Attack

Elemetal LLC faces a data breach class action resulting from its alleged failure to implement appropriate security measures, which led to a 2023 breach of approximately 13,000 customers’ personal information. Elemetal is a...more

BCLP

Artificial Intelligence Stays in the SEC's Cross-Hairs

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As news stories about AI have surged, so have enforcement actions by the SEC alleging fraudulent statements about AI capabilities....more

Alston & Bird

Combatting the New Insider Threat: North Korean IT Workers Posing as Remote Employees

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The New York Department of Financial Services issued a cybersecurity advisory on November 1, 2024, regarding a growing threat posed by North Korean operatives seeking remote IT roles at U.S. companies. These operatives secure...more

Alston & Bird

Treasury Finalizes Outbound Investment Regulations on China

Alston & Bird on

Effective January 2, 2025, a final rule by the Department of the Treasury restricts investments in certain emerging technology sectors. Our International Trade & Regulatory Group examines the impact of the new U.S. Outbound...more

Fish & Richardson

Texas Patent Litigation Monthly Wrap-Up: October 2024

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This post summarizes two federal patent cases from the Eastern District and Western District of Texas issued in October 2024. The decisions considered the defendants’ motions to stay the cases pending the resolution of inter...more

Parker Poe Adams & Bernstein LLP

What DOJ's Latest Guidance on Artificial Intelligence Corporate Compliance Means for Businesses

The U.S. Department of Justice (DOJ) recently updated its Evaluation of Corporate Compliance Programs (ECCP), which prosecutors consider when investigating, charging, and negotiating plea or other agreements with...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Akin Gump Strauss Hauer & Feld LLP

FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more

Goldberg Segalla

What the TFA! Is Trifluoroacetic Acid Another “Forever Chemical” on the Rise?

Goldberg Segalla on

A couple of months ago, our blog published an article on the exploding ubiquity of Trifluoroacetic acid (TFA) in the environment. TFA is a breakdown product of several hydrochlorofluorocarbons (HCFC). It is regulated under...more

Akin Gump Strauss Hauer & Feld LLP

FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more

Perkins Coie

Dissenting Commissioners’ Statement in SEC Cyber Disclosure Enforcement Actions May Forecast Change Ahead

Perkins Coie on

In late October, the SEC announced settled enforcement actions against four public companies, all stemming from impacts from the compromise of SolarWinds’ Orion software. Each order included allegations that the applicable...more

Winstead PC

HIPAA Gets a Potential Counterpart in HISAA

Winstead PC on

Americans hear about cybersecurity incidents on a frequent basis. As the adage goes, it is not a matter of “if” a breach or security hack occurs; it is a matter of “when.”...more

Jenner & Block

Client Alert: Beyond the Front Page: Five Things We’re Watching After Election Night

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This week, Donald Trump claimed a decisive victory in the presidential race, and Republicans picked up Democratic Senate seats in West Virginia, Ohio, and Montana, ensuring that they will flip the Senate and hold at least one...more

A&O Shearman

Bank of England Speech on Artificial Intelligence and Financial Stability

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The Bank of England has published a speech by Sarah Breeden, BoE Deputy Governor, Financial Stability, on AI and financial stability. In the speech, Ms. Breeden explores the novel features of Generative AI, and how financial...more

A&O Shearman

Draft Financial Services and Markets Act 2023 (Addition of Relevant Enactments) Regulations 2024 Published

A&O Shearman on

The draft Financial Services and Markets Act 2023 (Addition of Relevant Enactments) Regulations 2024 have been published, together with an explanatory memorandum. The Regulations add to the list of "relevant enactments" for...more

Sheppard Mullin Richter & Hampton LLP

California Limits Health Plan Use of AI in Utilization Management

California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health...more

Fenwick & West LLP

California’s SB 1120 Regulates AI in Health Plan Utilization Review and Management Activities Starting in January

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On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more

McGuireWoods LLP

Northern District of Indiana Excludes Battery Expert Opinions Based on Flawed Methods

McGuireWoods LLP on

On Sept. 30, 2024, the U.S. District Court for the Northern District of Indiana released an opinion and order excluding the opinions of a proposed lithium-ion battery expert. The now dismissed case, American Home Assurance...more

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