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The Promoting and Respecting Economically Vital American Innovation Leadership (“PREVAIL”) Act has moved to the Senate for a full vote after passing the Senate Judiciary Committee vote 11-10 on November 21, 2024. In celebrating the bipartisan passage of the bill, Senator Tillis, one of the bill’s sponsors, said that the bill will help “maintain the…

With 2024 coming to an end, it is time to dust off the quill and ink to put together a recap on privacy and artificial intelligence (AI) developments….By: Shook, Hardy & Bacon L.L.P.

On December 4, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in USA v. Mark Sorensen, case number 24-1557, and it is now taking under advisement a case that could have widespread effects as to what constitutes a “referral” under the Federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b)(2)….By: Quarles &…

Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal government’s position that manufacturers cannot do so without prior approval. The Health Resources and Services Administration (HRSA) has threatened two manufacturers with enforcement actions if they…

As 2024 comes to a close, the telehealth space continues to be uncharted territory. When the COVID-19 pandemic began, the ability to deliver telehealth expanded as providers sought to provide quality care unrestricted by physical, in-person requirements. Now, the issue has shifted to the other side of the telemedicine coin: Following this rapid expansion, facilitated…

PFAS (per- and polyfluoroalkyl substances) are a group of thousands of chemicals manufactured since the 1940s for use in consumer products and industrial processes. This article presents an overview of the PFAS phenomenon. PFAS are very effective at doing what they do – for example, resist grease, oil, water, and heat, and put out flammable…

Exploring Trends in California’s Proposition 65: Claims, Chemicals, Products, and More – California’s Proposition 65 (“Prop. 65”), the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, among other things, sellers of products to provide a “clear and reasonable warning” if use of the product results in a knowing and intentional exposure to one…

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended dates for the completion of consultations, delivery of legislation and subsequent implementation of reforms to the regulatory framework for medical…

Few injuries are as life-altering as paralysis. What makes this already devastating condition even more heartbreaking is when it results from a preventable medical error. Whether it’s due to a surgical mistake, a missed diagnosis, or a lapse in proper care, paralysis caused by medical negligence can leave victims and their families grappling with immense…

On December 14, 2024, Brighton Jones, LLC filed a notice of data breach with the Attorney General of Massachusetts after discovering that the company was recently targeted in an email phishing attack. In this notice, Brighton Jones explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information, which includes…