Digital Health & Technology
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May 29, 2025
Masimo Founder Slaps Board With Lawsuit Over His Ouster
The founder and former CEO of Masimo Corp. has alleged six of the medical technology company's directors orchestrated his wrongful termination and denied him the compensation he is now owed, according to a suit for hundreds of millions of dollars filed against the executives in California state court.
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May 27, 2025
1 Year In, Firms Grapple With Scope Of Wash. Health Data Law
A year after Washington’s landmark health privacy law took effect, attorneys are bracing for the first judicial interpretation defining the law's reach and closely watching a proposed class action. Copycat legislation, meanwhile, is emerging in other states.
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May 23, 2025
Meta, App Maker Flo Can't Escape All Of Privacy Class Action
A California federal judge ruled Thursday that Flo Health Inc. and Meta cannot escape all the claims in a class action brought by users of a menstrual cycle app who allege their privacy was violated, denying parts of both companies' summary judgment bids.
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May 23, 2025
Seattle Cancer Center Inks $11.5M Class Data Breach Deal
A Washington state judge has given final approval to an $11.5 million class action settlement to end litigation against Seattle-based Fred Hutchinson Cancer Center over a 2023 data breach that exposed patient information, with the judge awarding $3.8 million in attorney fees in a deal class counsel values at more than $50 million.
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Biotech Stockholders Challenge Director Pay Levels In Del.
Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.
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May 20, 2025
Sales Exec Admits Role In $70M Brain Scan Kickback Scheme
A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.
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May 20, 2025
NYU Langone IT Workers Get Conditional Cert. In Wage Suit
Information technology workers who accused New York University's academic medical center of improperly classifying them as exempt from earning overtime wages can proceed as a collective, a federal judge ruled, finding they showed they were all subject to the same pay policies and practices.
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May 16, 2025
Surgical Center Operator Inks $15M Deal Over Data Breach
Shields Health Group Inc., which runs dozens of MRI and surgical centers around New England, has agreed to pay around $15 million to resolve claims in a proposed class action stemming from a data breach that compromised the personal information of over 2 million people.
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May 15, 2025
Zuckerberg Can't Avoid Deposition In Meta Health Privacy Suit
A California federal judge on Wednesday refused to rethink her earlier order forcing Meta CEO Mark Zuckerberg to give a limited deposition in privacy litigation over a Facebook tool's alleged collection of patient health information, rejecting Meta's arguments that other executives are better suited to testify.
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May 14, 2025
Health Co. Founder Pleads Guilty In $5M Fraud Case
A Florida man who operated a health monitoring company geared toward keeping substance-addicted people from relapsing has admitted to bilking investors out of $5 million by misstating interest in the firm, the U.S. attorney's office in Philadelphia said.
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May 14, 2025
Virta Health's Diabetes Mission Is Personal For Its GC
Jamie Anderson said it's important to find a mission-driven company to join — and when that mission aligns with an attorney's personal life, it's even more inspiration to work hard and contribute to the success of the business.
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May 13, 2025
Becton Dickinson Sues Baxter Over Infusion Pump Patents
Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.
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May 13, 2025
4 Firms Seek $5M In $6.75M Seattle Hospital Web Privacy Deal
An unnamed plaintiff is urging a Washington state judge to give final blessing to an up to $6.75 million settlement to end allegations that a Seattle hospital system deployed source code on its website that divulged patients' private health information to Google and Facebook, with class counsel requesting another $5 million in fees.
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May 13, 2025
Split PTAB Cites SAS To Reject Samsung Petition
The Patent Trial and Appeal Board will not review whether a real-time interpretation patent for those hard of hearing is invalid after finding that only a quarter of Samsung's challenge could be successful, which isn't worth the full trial mandated by the U.S. Supreme Court.
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May 13, 2025
Former J&J, Moderna Exec Joins Goodwin Procter In Boston
Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.
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May 12, 2025
Will Justices Finally Rein In Universal Injunctions?
The U.S. Supreme Court is expected to address for the first time Thursday the propriety of universal injunctions, a tool federal judges have increasingly used to broadly halt presidential orders and policy initiatives, and whose validity has haunted the high court's merits and emergency dockets for more than a decade.
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May 12, 2025
AI Powers Next Wave Of Telehealth M&A After 2024 Uptick
Telemedicine-focused deal activity is poised for a transformative shift in 2025 as strategic buyers increasingly seek companies that embed artificial intelligence across their platforms, according to a new report from tech investment bank Drake Star.
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May 07, 2025
FDA Gets Win In Eli Lilly Weight Loss Drug Shortage Fight
A Texas federal judge on Wednesday refused to reverse a U.S. Food and Drug Administration decision to remove Eli Lilly & Co.'s popular weight loss drug from a national shortage list, denying a request from pharmacies that produce copycat doses of the drug and entering judgment in favor of the FDA.
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May 07, 2025
Masimo Unloads Embattled Audio Unit In $350M Sale
Samsung Electronics subsidiary Harman International has agreed to acquire Masimo Corp.'s consumer audio division, Sound United, for $350 million in cash, with Masimo taking a financial hit on the business it acquired three years ago for about $1 billion.
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May 05, 2025
High Court Won't Hear Challenge To Miss. Ban On Pot Ads
The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.
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May 02, 2025
Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant
Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.
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May 01, 2025
DaVita Hit With Class Actions Over Ransomware Attack
DaVita Inc. is facing at least two proposed class actions over a data breach the kidney care provider announced in April, with current and former patients alleging Wednesday in Colorado federal court that data thieves have already engaged in identity theft and fraud while DaVita has yet to offer details.

Foreign Drugmakers Brace For More Visits Amid FDA Cuts
The U.S. Food and Drug Administration's plan to expand surprise inspections of overseas drug manufacturing plants is a legitimate enforcement threat that should be taken seriously, even as the agency adjusts to a future with a smaller workforce.

Telehealth Coalition Director Talks Abortion Drug Battles
Since the overturning of Roe, abortion medications have become the most common method in the U.S. of ending a pregnancy. A co-founder of the Abortion Coalition for Telemedicine talks about the new legal battles over mifepristone, state shield laws, and a colleague facing criminal charges for sending abortion drugs through the mail.

Eli Lilly Opens New Front Against Weight-Drug Compounders
Pharma giant Eli Lilly is taking a new tack in its efforts to protect its lucrative weight-loss drugs by raising allegations that telehealth competitors are engaged in illegal corporate practice of medicine.
Expert Analysis
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International Ramifications Of Canada's Health AI Moves
Recent artificial intelligence developments in Canada's health industry are creating ripple effects for global investors, cross-border innovators and legal practitioners, and may create opportunities for U.S. companies rethinking their international strategies, says Atoussa Mahmoudpour at AMR Law.
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Maintaining Legal Compliance For GenAI In Life Sciences
As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.
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7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
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Compliance Lessons From Warby Parker's HIPAA Fine
The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.
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A Look At AI Benefits And Risks In Global Development Efforts
In areas like healthcare and law, artificial intelligence can play a transformative role in achieving the U.N.'s 2030 agenda for creating a more equitable, prosperous and sustainable world, but if not properly managed, AI could hinder global development efforts and widen existing gaps within society, say attorneys at Winston & Strawn.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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23andMe Case Highlights Privacy Complexities In Ch. 11
Attorneys at Pryor Cashman discuss the interplay between a sale of personally identifiable information and bankruptcy law in light of genetics and health company 23andMe's recent filing for Chapter 11 relief.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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How Health Cos. Can Navigate Data Security Regulation Limbo
Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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Dispelling 10 Myths About Health Provider-Based Compliance
Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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2024 Was A Significant Year For HIPAA Compliance
The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.