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Hogan Lovells

JPM 2026: FDA panelists prioritize faster approvals, national security, AI, and more

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Speaking at the 2026 J.P. Morgan Healthcare Conference, Hogan Lovells global regulatory partners Elizabeth Jungman and Brian Carey moderated a panel discussion with U.S. Food and Drug Administration (FDA) Deputy Chief of...more

Polsinelli

Supreme Court Grants Cert. Petition in Hikma / Amarin Skinny Labeling Case

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Key Takeaways: Supreme Court to decide if “generic version” marketing can support induced infringement claims. On Jan. 16, 2026, the Court granted Hikma’s petition for cert. in a closely watched case that could redefine...more

Hogan Lovells

JPM 2026: How to expand internationally while ensuring regulatory compliance - Rules for AI and trade in focus for the US, China,...

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As life sciences companies expand internationally, regulatory readiness must evolve into a strategic capability that supports global business planning and innovation....more

McDermott+

Healthcare Preview for the Week of: January 20, 2026

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Early on January 20, 2026, the House Appropriations Committee released the 2026 Consolidated Appropriations Act, which includes the last of the 12 fiscal year (FY) 2026 appropriations bills: Labor-Health and Human Services...more

Health Care Compliance Association (HCCA)

Healthcare technology and compliance: A complex patchwork of laws and regulations

Every day, we see the increasing role of technology in our healthcare world. It wasn’t all that long ago that we began the transition to electronic medical records, and portable devices mostly meant BlackBerries....more

Bradley Arant Boult Cummings LLP

First Circuit Holds That Labs Can Generally Rely on a Doctor’s Order as Proof of Medical Necessity Under the False Claims Act

Addressing an issue of first impression, the First Circuit has clarified the burden to satisfy the knowledge element required in False Claims Act (FCA) cases in the context of laboratory testing and Medicare fraud....more

Bass, Berry & Sims PLC

DOJ Releases Record-Setting Civil Fraud Recovery Statistics and Results…Our Annual Look Behind the Numbers

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On January 16, the U.S. Department of Justice (DOJ) released its annual report on civil fraud recoveries (settlements and judgments) for FY2025, along with a press release highlighting DOJ’s civil enforcement efforts....more

Ropes & Gray LLP

FDA Adapts with the Times on Digital Health: Updated Guidances on General Wellness Products and Clinical Decision Support Software

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On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness Policy for Low Risk Devices...more

McDermott Will & Schulte

TEMPO pilot enrollment begins: The race for digital health access is on

On January 2, 2026, the US Food and Drug Administration (FDA) began accepting statements of interest for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a program designed to accelerate access to digital...more

Ropes & Gray LLP

False Claims Act Insights: Key Takeaways from DOJ’s Fiscal Year 2025 Cases & Recoveries

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The U.S. Department of Justice (“DOJ”) announced last week that settlements and judgments under the False Claims Act (“FCA”) exceeded $6.8 billion in fiscal year 2025—a record-breaking figure and the highest in a single year...more

Maynard Nexsen

Work This Way: A Labor & Employment Law Podcast | Service Animals, the ADA, and Workplace Rights

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On this episode of Work This Way, Tina chats with fellow hosts and Maynard Nexsen attorneys Jennie Cluverius and Fay Edwards, along with a very special guest, Bing the pomsky, a service dog in training. Together, they break...more

Roetzel & Andress

Full Practice Authority APRNs in Illinois: Do You Still Need Supervision?

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Regulatory guidance from the Illinois Department of Financial and Professional Regulation (“IDFPR”) clarifies that med spas may be owned and operated by Advanced Practice Registered Nurses (“APRNs”), including those that...more

Carlton Fields

Connecticut Federal Court Denies Motion to Compel Discovery of Arbitrator’s Rationale for Decision

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In Plastic & Reconstructive Surgery Group v. Aetna, Inc., the U.S. District Court for the District of Connecticut addressed a motion filed by petitioner Plastic & Reconstructive Surgery Group to allow discovery of the reasons...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Lead Capital Invests in PedsOne

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Lead Capital Partners (LCP) has announced an investment in PedsOne. PedsOne, founded in 2011 and based in Nashville, Tennessee, is a provider of outsourced revenue cycle management and consulting services to independent...more

Akin Gump Strauss Hauer & Feld LLP

New Jersey’s New Year's PFAS Resolution

To ring in the new year, New Jersey became the latest state to enact legislation banning intentionally-added PFAS in certain consumer products. In the final days of his term, Governor Murphy signed into law the Protecting...more

Akin Gump Strauss Hauer & Feld LLP

DOJ Record Year of False Claims Act Enforcement Forecasts Even Greater Focus on the False Claims Act in 2026

On January 16, 2026, the Department of Justice (DOJ) issued its annual year-end report on civil False Claims Act (FCA) accomplishments and highlights from Fiscal Year (FY) 2025. This follows DOJ’s announcement only a week...more

Cozen O'Connor

FDA's Guidance on the Use of Real-World Evidence for Medical Devices

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Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The guidance outlines the FDA’s current thinking...more

Fenwick & West LLP

February 2026 Deadline: HIPAA Covered Entities Handling Substance Use Disorder Records Must Update Notices of Privacy Practices

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In February 2024, HHS finalized significant revisions to 42 CFR Part 2, the federal regulation governing the confidentiality of SUD treatment records. Part 2 has historically imposed stricter privacy protections than HIPAA,...more

Blank Rome LLP

DOJ Announces Record-Breaking False Claims Act Recoveries in FY 2025: What the Stats Portend for 2026

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Fiscal Year (“FY”) 2025 yielded a historic high of over $6.8 billion in False Claims Act (“FCA”) settlements and judgments, underscoring the Department of Justice’s (“DOJ”) aggressive enforcement. DOJ’s annual report,...more

Morgan Lewis

DOL Updates FY 2026 Health Plan Enforcement Priorities: What Employers Need to Know

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The US Department of Labor’s Employee Benefits Security Administration (EBSA) has announced updated enforcement priorities for fiscal year 2026. These changes signal where EBSA will focus its investigative and enforcement...more

Alston & Bird

Biological Products Regulation Part 2: What Is the Regulatory Pathway for Biological Products?

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Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more

Gordon Rees Scully Mansukhani

HHS and DEA Extend Telemedicine Flexibilities for Prescribing Controlled Medications Through 2026

The U.S. Department of Health and Human Services (HHS), working with the Drug Enforcement Administration (DEA), has issued a fourth temporary extension of telemedicine flexibilities, first introduced in response to the...more

Morgan Lewis

DOJ Announces Highest-Ever Annual False Claims Act Recoveries: Over $6.8 Billion in Fiscal Year 2025

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The US Department of Justice (DOJ) has announced that recoveries from False Claims Act (FCA) settlements and judgments in fiscal year 2025 exceeded $6.8 billion, the highest annual amount in FCA history and more than double...more

K&L Gates LLP

BIOSECURE Act: What You Need to Know

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The National Defense Authorization Act for Fiscal Year 2026, signed into law on 18 December 2025, includes the BIOSECURE Act (the Act), which establishes a new framework governing the use of certain biotechnology equipment...more

Axinn, Veltrop & Harkrider LLP

AI, Private Equity, and Fixes That Work: Key Takeaways from the FTC Alongside the JP Morgan Healthcare Conference

Against the backdrop of the San Francisco JPMorgan Healthcare Conference, Axinn, Cornerstone, and Concurrences hosted a reception and dinner on January 14, 2026, to discuss the Trump administration’s antitrust enforcement...more

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