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Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 13 - February 2025

Generally, the last day of a legislative week can end around noon. Not so for lawmakers today!  It turned into a hectic day with lawmakers pushing forward the people’s business so that they could return home for a long...more

Akerman LLP - Health Law Rx

Blizzard of Executive Orders Signals Trump Administration’s Healthcare Priorities

As harsh winter weather swept the nation’s capital, President Donald Trump commenced his second term by signing a blizzard of Executive Orders (EOs) that span many hot-button issues. Several of the EOs signal President...more

Bradley Arant Boult Cummings LLP

HHS’s Proposed Security Rule Updates Will Substantially Increase the Controls Needed to Comply with the Technical Safeguard...

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 tackling the proposed updates...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

Goodwin

EU Biosimilar Regulatory and Launch Updates

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CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more

Arnall Golden Gregory LLP

Industry Group Challenges Mental Health Parity Act Final Rules

On January 17, 2025, the ERISA Industry Committee (“ERIC”) filed a lawsuit against the U.S. Department of Health and Human Services and other federal agencies, seeking to invalidate the final rules under the Mental Health...more

Parker Poe Adams & Bernstein LLP

Third Circuit Upholds Verdict Against Home Health Agency Based on Employee Travel Time During Working Day

For most non-exempt employees, the Fair Labor Standards Act considers time spent traveling during the working day to be compensable working time. Last week, the Third Circuit Court of Appeals applied this principle to travel...more

Knobbe Martens

Heading Towards an Optimistic Initial Public Offerings (IPOs) Resurgence in 2025?

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On January 16th, 2025, GT Medical Technologies, announced that it has raised $37 million in Series D financing round. The financing round was led by Evidity Health Capital and joined by Accelmed Partners. Current investors...more

Goodwin

BioNTech Acquires Biotheus To Boost Oncology Strategy

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On February 3, 2025, BioNTech SE (“BioNTech”) confirmed the completion of its acquisition of biotechnology company Biotheus for an upfront payment of $800 million and up to $150 million in potential milestone payments. ...more

Amundsen Davis LLC

ICE at Health Care Facilities: Immigration Enforcement and Patient Privacy

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In the wake of increased federal enforcement of immigration policies, health care entities need to understand the impact those policies may have on their operations from a personnel and patient perspective. My colleague...more

Holland & Knight LLP

Massachusetts to Require License for Office-Based Surgical Centers

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Many existing office-based surgical centers in Massachusetts will soon be required to obtain a new type of healthcare facility license. Massachusetts Gov. Maura Healey signed House Bill No. 5159 into law on Jan. 8, 2025,...more

Seyfarth Shaw LLP

The Week in Weed: February 2025

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, Pennsylvania’s governor talks about legalization. ...more

Maynard Nexsen

Changes Proposed by HHS to Strengthen HIPAA Security Rule

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On January 6, 2025, the US Department of Health and Human Services Office for Civil Rights (“OCR”) issued a notice of proposed rulemaking (“Proposed Rule”) containing significant updates to the Security Rule under the Health...more

Gardner Law

State Licensing Requirements: Are You Prepared?

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Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

Health Care Compliance Association (HCCA)

We’ll Take the Fine: OCR’s ‘Unwarranted,’ Costly Demands Prompted Hospital’s $538K Payment

The saga that led Children’s Hospital Colorado to accept a fine of more than $500,000 imposed by the HHS Office for Civil Rights (OCR) began on July 11, 2017, when a physician’s email account containing details on 3,300...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

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With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Arnall Golden Gregory LLP

Lowering the Bar: Second Circuit Finds “At-Least-One-Purpose” Sufficient for Proving Anti-Kickback Statute Violation

On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 12 - February 2025

As the sun appeared on the horizon on Wednesday, so too did the House’s version of the Amended FY 2025 State Budget. Synchronized perfectly with sunrise over Atlanta at 7:30 a.m., the House Appropriations subcommittees...more

Arnall Golden Gregory LLP

Fourth Circuit Upholds OIG’s Unfavorable Advisory Opinion on Patient Assistance Program

On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more

Holland & Knight LLP

Holland & Knight Health Dose: February 5, 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

Pillsbury Winthrop Shaw Pittman LLP

IRS Eases Form 1095-C Burden for Employers

President Biden recently signed two new laws that significantly reduce the ACA compliance burden for employers by streamlining Form 1095 reporting and minimizing penalties for failure to file and distribute Form 1095s to...more

McDermott+

Regs and De-Regs: What to Watch Out for Next

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It is relatively quiet on the healthcare regulatory front. The Trump administration is currently filling out its leadership team within the US Department of Health and Human Services (HHS), with the confirmation process of...more

McDermott Will & Emery

California AG Issues Two AI Legal Advisories

On January 13, 2025, California Attorney General (AG) Rob Bonta issued two legal advisories: one for businesses generally (General Advisory) and one specific to healthcare entities (Health Advisory). These advisories identify...more

Goodwin

FDA Accepts BLA for Shanghai Henlius Biotech’s HLX11, a Pertuzumab Biosimilar

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​​​​​​​On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA....more

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