United States: Healthcare

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Virtual & Digital Health Digest
This digest examines the dual regulatory trajectory shaping virtual and digital health in mid-2026, as U.S. authorities intensify enforcement against telehealth fraud while simultaneously building institutional frameworks for artificial intelligence in healthcare delivery. The analysis tracks parallel developments in the EU and UK, where data protection authorities are scrutinizing automated decision-making systems and reassessing transatlantic data transfer mechanisms following recent U.S.
United States Healthcare
AP
Arnold & Porter
Article
D.C. Circuit Rebuffs Challenge To EPA’s PFOA And PFOS Hazardous Substance Rule
In April 2024, EPA designated perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). As previously discussed in Re:Torts, industry groups challenged the designation, arguing that EPA misread the phrase “may present substantial danger” as requiring only a “possibility” of harm. The groups also argued EPA gave inadequate notice of its cost-benefit methodology and acted arbitrarily and capriciously.
United States Environment
D
Dechert
Article
Seals And Sale Bans: California's New Non-UPF Certification And Age Limits On Dietary Supplements & OTC Diet Products
California continues to lead the way in regulating foods and dietary supplements sold within its borders. Two recent developments are worth highlighting: the nation’s first statewide “Non-Ultraprocessed” food certification program, and a second-of-its-kind law restricting sales of certain dietary supplements and over-the-counter products to individuals under 18. Below, we break down both measures and what they may mean for food and supplement companies doing business in the state.
United States Healthcare
AG
Akin Gump Strauss Hauer & Feld LLP
Article
Henry Ford Health Sues CVS Over Improper Diversion Of 340B Savings
Henry Ford Health has filed a federal lawsuit against CVS Health and its affiliates, alleging the improper diversion of over $29 million in savings from the federal 340B Drug Pricing Program through manipulated reimbursements for specialty drugs. The healthcare system claims CVS used back-end pricing mechanisms to retain funds that should have been remitted under their pharmacy services agreements, with similar allegations emerging from other major health systems across the country.
United States Healthcare
HB
Hall Benefits Law
Article
Where MedTech Is Attracting PE Attention With Less FDA Burden
Private equity firms are increasingly targeting medical device component manufacturers and servicing companies that benefit from FDA regulatory distinctions, creating investment opportunities with less direct regulatory complexity than traditional device manufacturers. Understanding where these regulatory advantages apply and how growth strategies might trigger additional FDA requirements is critical for sponsors looking to capture MedTech market growth while managing compliance obligations.
United States Finance
SR
McDermott Will & Schulte
Article
FinCEN’s Health Care Fraud Analysis: Investigating Suspicious Flows Without Treating Suspicion As Proof
FinCEN's September 2026 Financial Trend Analysis examines $17.5 billion in suspicious activity reports related to health care fraud, revealing critical patterns in Medicare, Medicaid, and private insurance payments. The analysis demonstrates how financial institutions can distinguish between suspicious transactions and proven fraud while improving their investigation methodologies. Understanding these patterns helps compliance teams build more effective transaction monitoring systems without conflating repo
United States Government
GU
Gesmer Updegrove LLP
Article
Banning Corporate Medicine: The Costs Congress Isn't Pricing In
Senators Warren, Wyden, and Merkley, along with Representatives Hoyle, Ocasio-Cortez, and Subramanyam, have introduced the Stop Corporate Takeovers of Physicians Act. The bill would establish the corporate practice of medicine doctrine, rooted in more than a century of law in about half of the states, as a federal baseline. The bill would require that licensed physicians be majority owners and controllers of medical practices and place limitations upon management services organizations.
United States Healthcare
M
Mintz
Article
D.C. Circuit Upholds Broad AKS Reach, Strikes Down HHS Advisory Opinion Timing Rules: Key Takeaways From Vertex Pharmaceuticals v. HHS
A federal appeals court has struck down HHS's regulatory tolling of advisory opinion deadlines and issued a sweeping interpretation of the Anti-Kickback Statute that affects patient support programs. The decision requires HHS to meaningfully engage with evidence submitted by requestors and enforces strict 60-day deadlines, fundamentally reshaping how life sciences companies navigate the advisory opinion process in a post-Loper Bright regulatory landscape.
United States Finance
FH
Foley Hoag LLP
Article
Your HIPAA Compliance Program Is About To Change
The U.S. Department of Health and Human Services appears ready to finalize significant revisions to the HIPAA Privacy Rule that could fundamentally alter how healthcare organizations handle patient information, access requests, and caregiver communications. Organizations that haven't updated their HIPAA compliance frameworks recently may face substantial policy, procedural, and operational changes affecting everything from privacy notices to health IT systems.
United States Healthcare
HL
Hogan Lovells Cadwalader
Article
Dualitas Therapeutics And Roche Enter Research Collaboration To Discover And Develop Bispecific Antibodies
Dualitas Therapeutics has entered into a research collaboration and license agreement with Roche to advance novel bispecific antibodies for immunology and inflammation diseases using Dualitas' DualScreen Bispecific Discovery Engine. The collaboration will functionally screen over 300,000 novel bispecific combinations to discover therapeutics with synergistic activities unattainable with conventional approaches.
United States Healthcare
GP
Goodwin Procter LLP
Article
DOL Provides Clarity On Mental Health Parity Enforcement: What FAB 2026-03 And The New Enforcement Guidance Tool Mean For Health Plan Sponsors
The Department of Labor's Employee Benefits Security Administration has issued new guidance clarifying enforcement priorities for mental health parity requirements under MHPAEA. This guidance narrows the focus to three key areas where treatment limitations on mental health and substance use disorder benefits may unlawfully differ from medical and surgical benefits. Health plan sponsors now have clearer direction on compliance expectations and enforcement focus areas.
United States Employment
CH
Calfee Halter & Griswold
Article
Before You Sign The AI Contract: A Practical Checklist For Healthcare Executives
Healthcare organizations are increasingly adopting AI tools for administrative tasks like scheduling, billing, and claims processing. While these technologies promise efficiency gains, the vendor agreements governing them require careful scrutiny to address data rights, HIPAA compliance, vendor responsibilities, and hidden costs that may not be apparent in initial discussions.
United States Healthcare
BS
Butler Snow LLP
Article
Healthcare Private Equity: A Look Into 2026 — Session Recap
Angela Humphreys and Wyatt Ritchie examine the evolving healthcare private equity landscape, analyzing M&A trends, buyer psychology shifts, and regulatory developments that are reshaping deal structures heading into 2027. The session reveals how large-scale transactions are driving market activity while state-level regulations and federal enforcement create new timing and structural challenges for healthcare investors.
United States Healthcare
BB
Bass, Berry & Sims
Article
How To Rethink Physician Alignment Without Breaking The Bank
Hospitals and health systems face mounting financial pressures from Medicaid cuts, reimbursement changes, and site-neutral payment shifts. Strategic physician alignment offers a cost-effective solution to strengthen margins, improve network integrity, and leverage underutilized regulatory flexibilities in the Stark Law and Anti-Kickback Statute to create innovative compensation structures and value-based arrangements.
United States Healthcare
SR
McDermott Will & Schulte
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