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Cozen O'Connor

Bipartisan AGs to Disposable E-Cigarette Companies: You’re Blowing Smoke

Cozen O'Connor on

A bipartisan group of ten AGs announced separate, coordinated efforts to take regulatory and enforcement action against companies allegedly importing, distributing, selling, and marketing flavored disposable e-cigarettes....more

McDermott+

Healthcare Policy Options to Reduce the Deficit

McDermott+ on

The Trump Administration and 119th Congress will likely be targeting trillions of dollars in savings in the year ahead. Healthcare makes up a significant portion of mandatory spending and therefore likely will be a large part...more

Fisher Phillips

New York on Verge of Enacting Sweeping Health Data Privacy Law: Answers to Your Key Questions and 6 Steps to Prepare

Fisher Phillips on

In a major development for all businesses handling health data, New York lawmakers passed a sweeping health data privacy bill Wednesday that could have far-ranging consequences across the country. S929, also known as the New...more

Foster Garvey PC

FDA’s New Rule for “Healthy” Claim Has Broad Implications for Food Industry

Foster Garvey PC on

The U.S. Food and Drug Administration (FDA) recently finalized its long-awaited rule for the use of "healthy" claims on food labels. The final rule brings welcome clarity for food companies but has broad legal and business...more

King & Spalding

DEA Announces Three New Telemedicine Rules

King & Spalding on

On January 16, 2025, the Drug Enforcement Administration (DEA) announced two final rules and a proposed rule for telemedicine flexibilities. In 2024, the DEA issued a one-year extension of the COVID-era telemedicine...more

Whiteford

Navigating Value-Based Care in Anesthesia: Enhancing Patient Outcomes Amid Legal Complexities

Whiteford on

Value-based care (VBC) is a healthcare delivery model that prioritizes patient outcomes over the volume of services provided. This approach aims to enhance the quality of care while controlling costs by incentivizing...more

Foley & Lardner LLP

New York’s Proposed Health Information Privacy Act Takes Aim at Digital Health Companies

Foley & Lardner LLP on

The New York Health Information Privacy Act (NYHIPA), if enacted, could create a chilling effect on patient access and engagement to readily available digital health care services relied upon by New Yorkers. Digital health...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Troutman Pepper Locke

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

Troutman Pepper Locke on

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

Hogan Lovells on

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

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