Expert Analysis

The Fate Of Biden-Era Clinical Study Guidance Under Trump

Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing... (more story)

10 Issues To Watch In Aerospace And Defense Contracting

This year, in addition to evergreen developments driven by national security priorities, disruptive new technologi... (more story)

Dispelling 10 Myths About Health Provider-Based Compliance

Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient... (more story)

Deals & Corporate Governance More

Trump Blocked From Implementing Anti-DEI Orders, For Now

A Maryland federal judge on Friday temporarily barred the Trump administration from implementing the bulk of his executive orders aiming to slash diversity, equity and inclusion programs in the public and priv... (more story)

Bank Says Nostrum's Second Investment Banker Unnecessary

Citizens Bank, a creditor of New Jersey drugmaker Nostrum Laboratories Inc., objected to Nostrum's request to retain another investment banker in its Chapter 11 case, arguing that Raymond James is already serv... (more story)

Olshan-Led Investor Picks Proxy Fight With Healthcare REIT

Land & Buildings Investment Management LLC, guided by Olshan Frome Wolosky LLP, said it nominated two candidates to National Health Investors Inc.'s board of directors on Wednesday, arguing that conflicts of i... (more story)

Digital Health Co. Beats Some Claims In SPAC Investor Suit

A New Jersey federal judge has dismissed, with leave to amend, claims in an investor suit against a blank check company that took digital health equipment venture Butterfly Network Inc. public, finding that so... (more story)

Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug

A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying... (more story)

Merck Investor Sues Over Gardasil China Market Projections

Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it reveal... (more story)

Digital Health & Technology More

Warby Parker Hit With $1.5M Fine After HHS Breach Probe

The U.S. Department of Health and Human Services announced Thursday that it has imposed a $1.5 million fine on Warby Parker Inc. following a cyberattack on the eyewear manufacturer's website that exposed the p... (more story)

Fed. Circ. Backs TTAB's Denial Of Health Co.'s Proposed TM

The Trademark Trial and Appeal Board correctly denied a healthcare management company's bid to register "Formularyhub" because it's a descriptive term, the Federal Circuit said Thursday.

Meta Should've Preserved Health Tracking Data, Judge Says

A California federal judge considering sanctions against Meta for deleting data in privacy litigation over a Facebook tool's collection of patient health information said Wednesday that he's not convinced Meta... (more story)

Tech Co.'s Software Doesn't Meet CMS Needs, Judge Says

A Court of Federal Claims judge denied IntelliBridge LLC's attempt to block the Centers for Medicare & Medicaid Services from seeking bidders for its hybrid cloud product engineering and operations contract, f... (more story)

Walgreens Says $1B COVID Testing Award Must Be Nixed

Walgreens is urging a Delaware federal judge to rethink his decision enforcing a $987 million arbitral award to a lab testing and diagnostics company in a dispute over COVID-19 tests, arguing Tuesday that he i... (more story)

Attys Talk AI Risks, Compliance At Health Law Conference

Amid the generative artificial intelligence boom, the healthcare industry is navigating the challenge of incorporating new technology — such as automated clinical documentation and fraud detection algorithms —... (more story)

Policy & Compliance More

Drugmakers Slam 'Untimely' Claims In Employers' Antitrust Suit

Pharmaceutical companies targeted by sweeping antitrust lawsuits from major employers, including Target, Lowe's and American Airlines, have asked a Pennsylvania federal judge to trim conspiracy claims from a l... (more story)

Watchdog Says DOL Struggles To Enforce Mental Health Law

Workers with mental health conditions and substance use disorders are at higher risk of not receiving treatment or having to pay out of pocket for care that should be covered because of the U.S. Department of ... (more story)

Wash. Health System Says Nurse Must Arbitrate Wage Claims

A Washington-based healthcare system facing a proposed class and collective wage action in Seattle federal court contends the plaintiff nurse agreed to arbitrate any claims with the third-party staffing agenci... (more story)

LGBTQ+ Health Orgs Aim To Halt Trump DEI, Gender Orders

Three executive orders by President Donald Trump barring federal contractors from pushing "gender ideology" and diversity-related programs violate the U.S. Constitution, a group of nonprofit LGBTQ+ organizatio... (more story)

NIH Research Cuts Stay On Hold As Judge Mulls Objections

A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and oth... (more story)

COVID Fraud Drove Record FCA Caseload, Gov't Officials Say

Federal officials said that the record-setting number of whistleblower False Claims Act cases filed in 2024 was likely driven by COVID-19-related fraud, with the use of data mining having an outsized role in those cases.