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Troutman Pepper Locke

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

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On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

McDermott+

Regs on the Menu for Rescission Under Budget Reconciliation

McDermott+ on

Over the next several weeks, both the Trump Administration and the 119th Congress will review the “menu” of Biden-era regulations that they may want to rescind or modify. In one of his first orders, President Trump (like...more

Sheppard Mullin Richter & Hampton LLP

Looking Back and Looking Forward: Healthcare Antitrust in a New Administration: What Stays the Same and What Changes?

President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down...more

Holland & Knight LLP

Holland & Knight Health Dose: January 21, 2025

Holland & Knight LLP on

Holland & Knight Health Dose 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

Bradley Arant Boult Cummings LLP

HIPAA Security Rule Updates: New Business for Business Associates

Bradley has launched a multipart blog series on the U.S. Department of Health and Human Services’ (HHS) proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, beginning last...more

McDermott Will & Emery

New York Governor Proposes Cost Market Impact Review, Expanded Disclosures for Material Transactions With Healthcare Entities

McDermott Will & Emery on

On January 21, 2025, New York Governor Kathy Hochul released the FY 2026 New York State Executive Budget, which proposed to impose a “cost market impact review” (CMIR) for certain “material transactions” involving “health...more

Skadden, Arps, Slate, Meagher & Flom LLP

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Adler Pollock & Sheehan P.C.

How an HSA Can Benefit Your Estate Plan

A Health Savings Account (HSA) can positively affect your estate plan. How? In addition to serving as a viable option to reduce health care costs, an HSA’s funds grow on a tax-deferred basis. In fact, an HSA is similar to a...more

Akin Gump Strauss Hauer & Feld LLP

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

Ropes & Gray LLP

Trade Group Sues Agencies Seeking to Invalidate Mental Health Parity and Addiction Equity Act Final Rules

Ropes & Gray LLP on

On January 17, 2025, the ERISA Industry Committee (“ERIC”), a national nonprofit trade association representing large employers that provide comprehensive health and retirement benefit programs to their workforces, filed a...more

Dickinson Wright

Arizona’s New Behavioral Healthcare Laws – Part 2

Dickinson Wright on

In 2024, the Arizona legislature passed five new Arizona laws directly affecting behavioral health care in Arizona. These laws run the gamut between refining definitions, requiring peer specialist trainings, new requirements...more

Wilson Sonsini Goodrich & Rosati

Navigating Pharmaceutical Patent Settlements and Reverse Payments: Key Takeaways from the FTC’s Latest MMA Reports

On January 16, 2025, the Federal Trade Commission (FTC) Bureau of Competition published four reports on pharmaceutical patent settlement agreements filed under the Medicare Prescription Drug, Improvement, and Modernization...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Morgan Lewis

Healthcare and Life Sciences: Key Insights and Considerations for Stakeholders in 2025

Morgan Lewis on

This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more

Cooley LLP

Cooley’s 2024 Life Sciences M&A Year in Review: M&A Slims Down in 2024, but Will Appetites Grow in 2025?

Cooley LLP on

With every new year comes reflection and resolutions. But as we go to press well into January, it is worth a reminder that studies show nearly 90% of New Year’s resolutions will have already failed by the end of the month....more

Hogan Lovells

UK confirms right to statutory neonatal care leave

Hogan Lovells on

Parents of babies that need hospital care shortly after birth will be entitled to neonatal care leave from April 2025. Leave is a day one right but pay is subject to service and earnings requirements. Employers should...more

Husch Blackwell LLP

Paid Sick Leave for Nebraskans Required in 2025

Husch Blackwell LLP on

In the November 2024 election, Nebraska voters passed Initiative 436, also known as the Nebraska Healthy Families and Workplace Act. This law mandates paid sick leave for most employees in the state and takes effect October...more

Paul Hastings LLP

HHS OCR Releases Proposed Updates to HIPAA Security Rule

Paul Hastings LLP on

On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through the Office for Civil Rights (OCR), announced a Notice of Proposed Rulemaking (NPRM) to amend the Security Standards for the Protection of...more

Stevens & Lee

FTC Settlement Proposes Consent Order to Monitor Private Equity Firm Welsh Carson’s Acquisitions Plans

Stevens & Lee on

We previously reported on the Federal Trade Commission’s (FTC) lawsuit against U.S. Anesthesia Partners (USAP) and the private equity firm Welsh, Carson, Anderson & Stowe (Welsh Carson). In the lawsuit, the FTC alleges that...more

McDermott Will & Emery

This Week in 340B: January 14 – 20, 2025

McDermott Will & Emery on

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

McCarter & English, LLP

FTC Issues PBM Report Signaling Consolidation Is Impacting Pharmaceutical Prices

At a public meeting held on January 15, 2025, the Federal Trade Commission (FTC) summarized the Second Interim Staff Report (Second Report) stemming from its investigation into pharmacy benefit managers (PBMs) and their...more

Groom Law Group, Chartered

Supreme Court to Decide Legality of ACA’s Preventive Services Mandate

On January 10, 2025, the Supreme Court agreed to hear an appeal in Becerra v. Braidwood Management, Inc. (“Braidwood”). The case (discussed in a prior Groom alert), on appeal from the Fifth Circuit, will determine if the...more

Fisher Phillips

Biden’s OSHA Abandons COVID-19 Regulation in Favor of Broader Infectious Disease Standard: What Healthcare Employers Need to Know

Fisher Phillips on

In the waning days of the Biden administration, federal workplace safety officials finally scrapped plans to finalize an outdated COVID-19 regulation – but started the ball rolling on a broader infectious disease standard...more

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