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BCLP

California Turns to the Use of AI in Healthcare

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In another example of the patchwork of AI laws quietly coming into force across the US, California passed at the beginning of this year a new law regulating the use of certain AI technologies by some types of healthcare...more

Seyfarth Shaw LLP

Federal Lawsuit and Tri-Agency Report Shake Up Mental Health Parity

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On January 17, 2025, the U.S. Departments of Treasury, Labor and Health and Human Services (the “Agencies”) released its annual report to Congress assessing compliance with statutory mental health parity requirements under...more

Troutman Pepper Locke

RICO's Person/Enterprise Distinction - RICO Report Podcast

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Join Troutman Pepper Locke White Collar and Litigation Partner Cal Stein for a special podcast series, discussing the legal landscape surrounding the Racketeer Influenced and Corrupt Organizations Act (RICO). In this...more

Cozen O'Connor

Democratic AGs Secure Order Blocking Cuts to NIH-Funded Research Grants

Cozen O'Connor on

A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

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The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

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In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Morris James LLP

Urgent Tuna Recall: Understanding the Botulism Risk

Morris James LLP on

A recent recall of certain canned tuna products sold at major retailers such as Costco, Trader Joe's, and Walmart has raised concerns about botulism, a rare but potentially fatal illness. The recall was issued due to a...more

McGuireWoods LLP

Proposal Would Introduce Approval Requirement on Healthcare Transactions in Indiana

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On Jan. 21, 2025, Indiana legislators introduced a new bill in the Indiana House of Representatives targeting healthcare transaction reporting and healthcare provider ownership disclosures (the IN Bill). The IN Bill proposes...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, February 13, 2025

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Gov. Shapiro Sues Trump Admin. Over $2B Federal Funding Freeze -Governor Josh Shapiro has filed a lawsuit against the Trump administration for allegedly withholding over $2 billion in federal funds from Pennsylvania, despite...more

Greenbaum, Rowe, Smith & Davis LLP

Criminalizing Reproductive Care and Abortion Services through Telehealth

The January 30, 2025 issue of the New England Journal of Medicine contains an article entitled “Providing Interstate Telehealth Abortion Services to Patients in Restrictive States.” In the second sentence, the authors write:...more

Foley & Lardner LLP

Understanding the Legal Pitfalls of Virtual Second Opinions: What You Need to Know

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Virtual medical second opinion (VSO) programs continue to roll out across the country, delivering expert recommendations to better help patients’ diagnoses or treatment options. These VSO programs can offer immense value to...more

Cozen O'Connor

Republican AGs Have Beef with Nutritional Standards Report

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Twenty-three Republican AGs submitted a comment letter to HHS and Department of Agriculture officials opposing aspects of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee; the Dietary Guidelines are...more

Alston & Bird

False Claims Act FY 2024 Update: Increase in Overall Recoveries, Decrease in Whistleblower Awards – Constitutional Questions...

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Our False Claims Act Team highlights key FCA enforcement trends in 2024, including the continued focus on health care fraud by the Department of Justice (DOJ)....more

Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

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Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Arnall Golden Gregory LLP

Insights From the 2025 American Health Law Association’s Long Term and Post-Acute Care Law and Compliance Conference

This year, health lawyers, providers, consultants, and government experts from across the country convened in Orlando, Florida, for the American Health Law Association’s Long Term and Post-Acute Care Law and Compliance...more

Robins Kaplan LLP

New ANDA Cases - Winter 2024

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Troutman Pepper Locke

DOJ and 18 States Reach False Claims Act Settlement with QOL

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The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more

Wyrick Robbins Yates & Ponton LLP

First Lawsuit Filed under Washington’s My Health My Data Act

After Washington adopted the My Health My Data Act (MHMDA) almost two years ago, we and others predicted that the law would lead to a wave of private lawsuits against companies operating in or adjacent to the health space....more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Knobbe Martens

Zimmer Biomet to Acquire Paragon 28

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Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28 at approximately $1.1...more

McDermott Will & Emery

This Week in 340B: February 4 – 10, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Bradley Arant Boult Cummings LLP

HHS Security Rule NPRM Proposes Makeover for Administrative Safeguard Compliance for Regulated Entities

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Knobbe Martens

BD Announces Restructuring to Focus on Medical Technology

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On February 5, 2025, Becton, Dickinson and Company (BD) announced plans to separate its Biosciences and Diagnostic Solutions business into an independent entity. The Biosciences and Diagnostic Solutions business is reportedly...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 222: Hospital Response to Hurricane Helene with Jay...

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Last fall, Hurricane Helene devastated the western Appalachian region of North Carolina. Jay Kirby, the CEO of UNC Health Pardee, joins us on the podcast this week to discuss how the hospital responded to the challenges and...more

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