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Expert Analysis

Prepare For Increased FDA Inspections Of Foreign Facilities

In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspecti... (more story)

Legacy Of 3 Justices Should Guide Transgender Rights Ruling

Three Republican-appointed U.S. Supreme Court justices — Anthony Kennedy, Sandra Day O'Connor and David Souter — g... (more story)

How Medical Practices Can Improve Privacy Compliance

In light of recent high-profile patient privacy violations, health practices — especially in California — should b... (more story)

Deals & Corporate Governance More

Ga. Panel Affirms Emory's Early Win In Neonatal Care Suit

The Georgia Court of Appeals said a trial court rightly freed Emory Healthcare from a suit alleging that a nurse in the neonatal intensive care unit failed to spot an intravenous line infiltration that left a ... (more story)

Spectrum Pharma Investors Get Initial OK For $16M Deal

A Nevada federal judge has given the first green light to a nearly $16 million settlement between a pharmaceutical company and a class of investors who claimed the company and its executives overstated the sta... (more story)

Attorneys Say Look Before Leaping Back Into Senior Housing

Attorneys advising on senior housing deals are seeing more interest from investors and developers, due to demographic trends and the post-pandemic recovery, but emphasize the unique legal considerations of a s... (more story)

FDA Dodges Suit Over Ozempic, Wegovy Listing

The U.S. Food and Drug Administration was able to escape allegations that it catered to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic, after a Texas federal judge tossed a lawsu... (more story)

InnovAge IPO Investors Get Initial OK Of $27M Settlement

A Colorado federal judge has preliminarily approved a $27 million settlement between InnovAge Holding Corp., its underwriters and a class of stockholders accusing the senior-health care company of making misle... (more story)

Cancer Diagnostics Firm, Insurer Price 2 IPOs Totaling $902M

Cancer-diagnostics test provider Caris Life Sciences Inc. and coastal-focused residential insurer Slide Insurance Holdings Inc. will begin trading Wednesday after pricing two initial public offerings that rais... (more story)

Digital Health & Technology More

Medical AI Co. Calls Rival's Suit A Ploy To Kill Competition

A Canadian artificial intelligence company focusing on medical information has asked a Massachusetts federal judge to toss out a recent trade secrets lawsuit, saying the complaint is an attempt to thwart compe... (more story)

5 Open Questions About FDA's AI-Assisted Review Plans

The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarke... (more story)

IP, Health Law Scholars Object To 23andMe Ch. 11 Data Sale

A number of university scholars urged a Missouri bankruptcy judge to require that DNA testing company 23andMe Holding Co.'s asset sale be contingent on the final buyer maintaining policies that benefit biomedical researchers.

VA Contractor To Pay $4.3M To Resolve Overbilling Claims

Healthcare technology company Omnicell Inc. has agreed to pay more than $4.3 million to settle allegations it fraudulently overcharged the U.S. Department of Veterans Affairs for medical products and software,... (more story)

States Sue To Block 23andMe From Selling DNA Data In Ch. 11

A bipartisan coalition of 28 attorneys general has sued 23andMe Inc. in Missouri bankruptcy court seeking to block the genetic-testing company from auctioning off its 15 million customers' personal genetic inf... (more story)

Health Records Co. Looks To Toss Patient Data Access Case

PointClickCare is urging a Maryland federal court to toss a case seeking to force the medical records company to allow Real Time Medical Systems to access patient data with automated bots after the Fourth Circ... (more story)

Policy & Compliance More

NC Panel Rejects HCA Unit's Appeal Over Rival Project Award

A North Carolina appeals court on Wednesday rejected an HCA Healthcare subsidiary's challenge to an award of a certificate of need allowing a rival to build a new acute care facility, backing a decision in fav... (more story)

Nurse Staffing Exec Can't Nix Conviction, Sanctions Floated

A Nevada federal court has refused a nurse staffing executive's bid to undo his conviction on wage-fixing and wire fraud charges, and threatened his attorneys with sanctions for allegedly making repeated misre... (more story)

High Court Concurrences Signal Hard Battle For Trans Rights

U.S. Supreme Court Justice Amy Coney Barrett joined the court's two most conservative members Wednesday to suggest laws that differentiate based on transgender status should be subject to the lowest level of j... (more story)

NY High Court Lifts Block On NYC Shifting Retiree Healthcare

New York's highest court lifted an injunction Wednesday that had blocked New York City from switching retired city employees' health insurance provider, ruling that the city never promised its retirees that it... (more story)

Ex-Drug Exec Must Testify, But Keeps 5th Amendment Rights

Sandoz, Teva, Actavis and Taro can again subpoena the deposition testimony of a former Actavis and Teva executive, but a Pennsylvania federal judge is still allowing the witness to invoke his Fifth Amendment r... (more story)

Age Bias Taints Kansas Health Dept. Promotions, EEOC Says

The Kansas Department of Health and Environment overlooked an older worker for promotions to more senior lab tech roles solely because of her age, the U.S. Equal Employment Opportunity Commission told a federal court.