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Goodwin

The 43rd Annual J.P. Morgan Healthcare Conference Starts Today - A Who’s Who in Biologics at this Year’s Conference

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The JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Holland & Knight LLP

Podcast - Rewriting the Narrative of Private Equity in Healthcare

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In this episode of "Counsel That Cares," Healthcare Transactions attorneys David Marks and Eric Scalzo, along with Chartis Strategic Innovation Partners Sri Mani and Eric Mayeda, discuss the increasing scrutiny of...more

Ankura

From Technology-Enabled Healthcare Solutions to Hospitals: Unveiling Key Trends in Healthcare Mergers and Acquisitions

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Ankura is pleased to present an overview of healthcare services transactions announced or closed during Q3 2024 in the United States. The total number of transactions decreased by 2.8 percent in the third quarter of 2024,...more

Gardner Law

Breaking the Ice: FDA-focused firm leader sees benefits in AI

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Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations. ...more

Foley & Lardner LLP

Non-Competes: New Limits for Pennsylvania Health Care Practitioners

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Pennsylvania’s new law, the Fair Contracting for Health Care Practitioners Act (the Act) went into effect on January 1, 2025. This law restricts the ability of employers and health care practitioners to enter into non-compete...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

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Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

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On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

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On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Dentons

Ep. 44 – Three Ways to Reenergize Your Compliance Programming for 2025

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As we start a new year, January is a great time to plan ways to refresh your compliance programming for the upcoming year. Compliance training and activities can become stale. They often take a backseat to the day-to-day...more

McDermott+

McDermott+ Check-Up: January 10, 2025

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119th Congress Begins. The new Congress began with key membership announcements for relevant healthcare committees. Cures 2.1 White Paper Published. The document outlines the 21st Century Cures 2.1 legislative proposal,...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

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Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

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We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

Baker Donelson

Proposed HIPAA Security Rule Updates

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) on December 27, 2024, to update the Health Insurance Portability and Accountability Act...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #1

News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more

Alston & Bird

Updates to the Dietary Guidelines? HHS and USDA Request Public Input

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Our Food & Beverage Team discusses how looming changes to federal dietary guidelines and new Make America Healthy Again initiatives could impact the food and beverage industry in 2025....more

Alston & Bird

Health Care Week in Review: CMS Releases Advance Notice of MA and Part D Payment Methodologies and Senate Finance Chair Identifies...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Stikeman Elliott LLP

Federal Government Announces Policy on Canada Health Act Status of Payments to Regulated Healthcare Professionals Providing...

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Friday, the Federal Government issued correspondence to the provinces and territories regarding its newly introduced Canada Health Act Services Policy. As set out in this correspondence from the Minister of Health, the CHA...more

McDermott Will & Emery

Trending in Telehealth: December 18, 2024 – January 6, 2025

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

Bass, Berry & Sims PLC

Massachusetts HB5159 Expands Oversight of Private Equity Investment in the Health Care Industry

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On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more

Venable LLP

More States Consider Age Restrictions for Certain Weight Loss or Muscle-Building Products

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On January 8, 2025, a bill prohibiting the sale of certain dietary supplements for weight loss and muscle building and other products to minors was formally introduced to the Virginia House of Delegates (House Bill No. 1585...more

Sheppard Mullin Richter & Hampton LLP

Building a Smarter Long-Term Care System in New York

New York State has a long-standing commitment to supporting its most vulnerable populations through Medicaid-funded services for older adults and those requiring long-term care. However, rising costs and an increasingly...more

Fenwick & West LLP

Some AI-Discovered Drugs Carry More IP Risks Than Others - Here's Why

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AI is poised to revolutionize drug discovery, but uncertainty in developing protectable IP in this emerging field creates a host of potential risks for companies innovating in this space. Further complicating things: not all...more

Goodwin

Year in Review: Top Regulatory Developments of 2024

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As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more

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