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Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2025 #1

News Briefs - Visa Restrictions Impacting Hospitals Awaiting Foreign Residents - Some hospitals in the U.S. are without essential staff because international doctors who were set to start their medical training were delayed...more

Holland & Knight LLP

Holland & Knight Health Dose: July 15, 2025

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The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Hogan Lovells

Medicines shortages under the EU pharma law package

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The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Morrison & Foerster LLP

Trump Antitrust Enforcers Take Aim at High Drug Costs, With Uncertain Path Forward

Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences...

Maynard Nexsen on

This week, Lynnsey and Lauren are joined by Maynard Nexsen attorney Jennifer McEwen, who helps clients with business planning, estate and trust planning, and tax planning. Jennifer shares essential business strategies for...more

Cooley LLP

Janssen v. Teva: Federal Circuit Upholds Claims to Pharmaceutical Dosing Regimen, Clarifies Presumption of Obviousness for...

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On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more

Hogan Lovells

2025 NMPA Inspection points for clinical trials of medical devices

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Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and...more

Morgan Lewis

AI in Healthcare: Opportunities, Enforcement Risks and False Claims, and the Need for AI-Specific Compliance

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The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

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On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Cozen O'Connor

Pennsylvania Perspective for Monday, July 14, 2025

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PA Outlaws Creation of Deepfakes with Malicious Intent - Governor Josh Shapiro (D) signed a bill that will code deepfakes as forgeries, making misleading or malicious digital impersonations illegal. The first offense will be...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Gould + Ratner LLP

What Employers Need to Know About the Employee Benefits Provisions in the OBBBA

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On July 4, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law with President Donald Trump’s signature. Although the OBBBA’s tax and spending provisions tend to receive greater media attention, it also contains...more

Ballard Spahr LLP

The OBBBA’s Impact on Employee Benefits and Executive Compensation

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H.R.1—the One Big Beautiful Bill Act (OBBBA)—contains several provisions that directly affect employer-provided benefit programs, primarily health and welfare programs....more

McDermott+

Healthcare Preview for the Week of: July 14, 2025

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Rescissions rescissions - Congressional focus this week is on the rescissions package and appropriations. The rescissions bill has a July 18 deadline to reach the president’s desk for signature. The bill is pending in the...more

Schwabe, Williamson & Wyatt PC

Changes to Employee Benefit Plans in the One Big Beautiful Bill Act

On July 4, 2025, the One Big Beautiful Bill Act, 2025 (OBBBA) was enacted. The OBBBA is far-reaching and employers may need to do a lot of work to bring their systems and procedures into compliance. Some of the changes in the...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025) Our Case of the Week focuses on obviousness. More particularly, the decision included a lengthy...more

Hogan Lovells

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

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The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

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Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

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On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more

Foley & Lardner LLP

Gender-Affirming Care: Key Takeaways from FTC’s July 2025 Workshop on Unfair Or Deceptive Trade Practices

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On July 9, 2025, the Federal Trade Commission (FTC) hosted a workshop focused on perceived “dangers” arising from unfair or deceptive trade practices in marketing a variety of health care services falling under the label of...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

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In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

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Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....more

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