Digital Health & Technology

  • April 09, 2025

    23andMe Asks For Independent Customer Data Rep In Ch. 11

    Genetic testing company 23andMe asked a Missouri bankruptcy judge to let it appoint an independent customer data representative as it looks to sell genetic data of 15 million users at a Chapter 11 auction.

  • April 07, 2025

    Fla. Man Pleads Guilty In $8.4M Medicare ID Fraud Case

    A Fort Lauderdale man has pled guilty in Florida federal court to criminal charges accusing him of illegally buying Medicare identification numbers and using those numbers to help submit $8.4 million in false Medicare claims.

  • April 03, 2025

    Hospital Group Urges 4th Circ. To Undo Data Access Order

    Industry groups representing hospitals and health data companies have urged the Fourth Circuit to rethink its panel's dismissal of an appeal over an order forcing an electronic medical records company to let a nursing data company access patients' information, saying the order creates a financial burden on the healthcare system.

  • April 02, 2025

    Congress Demands VA Update Health Record System Costs

    A bipartisan group of congressional leaders has sent a letter demanding that the U.S. Department of Veterans Affairs update its schedule and cost estimate for its problem-ridden, multibillion-dollar electronic health record modernization program, just as the VA announced it would roll out the system to nine additional sites in 2026.

  • April 02, 2025

    Zoll Gets Parts Of Data Breach Class Action Tossed

    A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.

  • April 02, 2025

    Orthodontic Software Co. Hit With Data Breach Class Action

    An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.

  • April 01, 2025

    The Loss For Litigants In Federal LGBTQ Data Rollback

    Brad Sears of UCLA School of Law’s Williams Institute talks about the fight to expand LGBTQ representation in federal datasets and the threat to litigants if surveys capturing the information are stopped amid a Trump administration purge.

  • April 01, 2025

    IBM And J&J Beat 'Speculative' Data Breach Suit, For Now

    A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.

  • March 31, 2025

    Texas Judge Deems Lab-Test Rule Outside FDA Authority

    A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."

  • March 31, 2025

    Buyer Class Of Surgical Robots Is Certified In Antitrust Fight

    A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.

  • March 31, 2025

    FTC Chair Flags Data Risks In 23andMe Bankruptcy

    The Federal Trade Commission has added to the swell of privacy and security concerns surrounding the potential sale of sensitive consumer information swept up in the 23andMe bankruptcy, with the agency's Republican chair on Monday stressing the importance of data continuing to be protected in the way that users have been promised. 

  • March 27, 2025

    Meet The Attys Helping 23AndMe Through Ch. 11

    DNA testing company 23andMe Holding Co. enlisted a group of attorneys from Carmody MacDonald PC and Paul Weiss Rifkind Wharton & Garrison LLP to help it address $214 million in debt as it tries to sell its business through Chapter 11.

  • March 26, 2025

    Sotomayor Urges Caution On Nondelegation Doctrine Revamp

    U.S. Supreme Court Justice Sonia Sotomayor cautioned her colleagues during oral arguments Wednesday against using a challenge to the Federal Communications Commission's administration of a broadband subsidy program as a way to resurrect the long-dormant nondelegation doctrine. Several conservative justices, however, seemed willing to disregard that admonition.

  • March 26, 2025

    23andMe Says Ch. 11 Privacy Ombudsman Not Required

    DNA testing company 23andMe Inc.'s customer data will be protected in Chapter 11, its attorneys told a Missouri bankruptcy judge Wednesday as it argued that the appointment of a consumer privacy ombudsman is not required.

  • March 25, 2025

    Catching Up With New Bankruptcy Case Action

    23andMe Holding Co. entered Chapter 11 to sell its business and address $214 million in debt; Danimer Scientific Inc., which makes plastics alternatives, entered Chapter 11 to wind down while it tends to its roughly $450 million debt burden; and sneaker shop Soleply began a streamlined bankruptcy for small businesses in an effort to exit some lease obligations and restructure its debt.

  • March 24, 2025

    Period App Users Get $3.5M In Privacy Deal With Analytics Co.

    A defunct mobile analytics company caught up in a proposed class action alleging a menstruation tracking app impermissibly shared health information with Google and others has agreed to a $3.5 million settlement with app users, given its "limited pool of funds," app users informed a California federal court on Friday.

  • March 24, 2025

    Children's Hospital Axes Suit Over Meta Info Sharing, For Now

    A Minnesota federal judge tossed a proposed class action alleging a children's hospital used ad tracking software on its website that disclosed minor patients' sensitive information with Meta Platforms Inc., Google LLC and other third parties, saying the patients' parents don't have standing to sue.

  • March 24, 2025

    Seattle Biotech Duped Investors On Drug Progress, Suit Says

    Seattle's Sana Biotechnology Inc. is the target of a proposed class action filed on Monday by a shareholder who alleges the company misled investors about its ability to develop genetic therapy treatments for oncology and central nervous system disorders.

  • March 24, 2025

    DNA Testing Firm 23AndMe Files Ch. 11 With Plans To Sell

    DNA testing company 23andMe Inc. filed for Chapter 11 protection in Missouri bankruptcy court, listing $214 million of debt and saying it plans to sell its business through the bankruptcy process.

  • March 20, 2025

    Atrium Health Escapes Privacy Suit Over Meta Data Sharing

    A North Carolina federal judge on Thursday tossed a proposed class action accusing Atrium Health Inc. of unlawfully sharing patients' private information with Meta Platforms and Google through browser tracking tools, finding the allegations couldn't proceed in his court but leaving the door open for the plaintiffs to refile negligence, contract and other claims in state court. 

  • March 19, 2025

    Law360 Announces The Members Of Its 2025 Editorial Boards

    Law360 is pleased to announce the formation of its 2025 Editorial Advisory Boards.

  • March 18, 2025

    AI Healthcare Co. Accuses Test-Maker Of Infringing Patents

    Artificial intelligence-powered diagnostics company Tempus AI has accused medical test-maker Guardant Health of infringing numerous patents related to healthcare records platforms and ways of pinpointing patient biomarkers.

  • March 12, 2025

    4th Circ. Won't Undo Health Data Access Order

    A Fourth Circuit panel issued a ruling Wednesday that affirmed a lower court's order requiring PointClickCare to allow Real Time Medical Systems to access patient data that it uses to provide nursing facilities with alerts for potential medical complications.

  • March 12, 2025

    Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict

    A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.

  • March 11, 2025

    Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App

    A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.

Expert Analysis

  • Assessing Algorithmic Versus Generative AI Pricing Tools

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    A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.

  • What FCA Cases May Look Like In The Age Of Generative AI

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    Generative artificial intelligence raises unique considerations both in the context of potentially leading to False Claims Act cases and in the discovery and litigation phases of these lawsuits, says attorney Rachel Rose.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

  • How Cos. With Chinese Suppliers Should Prep For Biotech Bill

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    A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

  • The Road Ahead For Regulation Of Digital Twins In Healthcare

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    Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

  • After Chevron: Slowing Down AI In Medical Research

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    The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • What's New In The AI Healthcare Regulatory Space

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    Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.

  • 3 Policyholder Tips After Calif. Ruling Denying D&O Coverage

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    A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.

  • How Tech Trackers May Implicate HIPAA After Hospital Ruling

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    A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • After Chevron: FDA Regulations In The Crosshairs

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    The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

  • After Chevron: Expect Few Changes In ITC Rulemaking

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    The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.