Digital Health & Technology

  • May 31, 2024

    Samsung Strikes First With Smart Ring IP Suit Against Oura

    Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings. 

  • May 30, 2024

    FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security

    The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit. 

  • May 30, 2024

    Veradigm Execs Sued Over Company's Nasdaq Delisting

    Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.

  • May 29, 2024

    Greenberg Traurig Adds IP Atty From Eversheds Sutherland

    Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.

  • May 28, 2024

    Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team

    RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.

  • May 24, 2024

    Fla. Lab Owner Will Pay $27M To End False Billing Suit

    A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.

  • May 23, 2024

    Stryker Unit And Seyfarth Attys Hit With $275K Sanctions

    A Colorado federal judge has imposed $275,000 in sanctions jointly and severally on Stryker-owned Howmedica Osteonics Corp., along with Seyfarth Shaw LLP, for witness coaching and discovery violations in a bitter breach-of-contract dispute, amounting to roughly one-eighth of what plaintiff ORP Surgical LLC had sought.

  • May 22, 2024

    Stryker Agrees To Settle Calif. Misclassification Suit

    Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.

  • May 22, 2024

    Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects

    Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.

  • May 21, 2024

    Amid Abortion Suit, Ind. Officials Spar Over Report Releases

    Indiana's top lawyer is set to respond to a lawsuit seeking access to doctor-created abortion reports. The case promises to highlight a rift between the state's vocally anti-abortion attorney general and other officials who say the information is off-limits to public records requests.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Ga. OB-GYN Office Says Data Breach Class Action Falls Flat

    An Atlanta OB-GYN practice has urged a Georgia federal judge to dismiss a proposed class suit over a data breach that allegedly impacted the personal and protected health information of tens of thousands of patients, arguing the lead plaintiff has failed to meet the requirements of the Class Action Fairness Act.

  • May 15, 2024

    Blackbaud Dodges Data Breach Victims' Class Cert. Bid

    A South Carolina federal judge has refused to certify several proposed classes consisting of roughly 1.5 billion patients, donors and other individuals whose personal information was allegedly swept up in a 2020 ransomware attack on software provider Blackbaud Inc., finding that the plaintiffs had failed to show that class members could be easily identified. 

  • May 15, 2024

    UnitedHealth Concealed DOJ Merger Investigation, Suit Says

    UnitedHealth Group has been hit with a proposed shareholder class action alleging that it failed to disclose that the U.S. Department of Justice had reopened an antitrust investigation into the health insurance giant following its acquisition of a healthcare data company, and that top executives had sold more than $120 million of shares knowing about the investigation before a news report revealed it to the public.

  • May 14, 2024

    Under Fire For Lab Rule, FDA Remains Open To Lawmaking

    After a difficult run-up to a new federal rule on lab-developed tests, the U.S. Food and Drug Administration official overseeing medical devices voiced support Tuesday for additional lawmaking.

  • May 13, 2024

    Wash. Hospital Scores Exit In Facebook Privacy Suit, For Now

    A Washington federal judge has tossed a proposed class action accusing a Seattle-area hospital of sharing patients' confidential health information by using Facebook browser tracking tools, ruling on Monday the plaintiff has failed to show that her own private information was input into the website and shared with a third party.

  • May 13, 2024

    Philips Wants Cleaner Co. To Chip In For $1B CPAP Deal

    Koninklijke Philips NV has filed a third-party complaint in Pennsylvania federal court against SoClean Inc., which sells cleaning products for breathing devices, claiming SoClean and its parent should contribute to Philips' $1 billion settlement because its cleaners allegedly exacerbated the foam breakdown at the heart of the litigation.

  • May 10, 2024

    Retail Group Opposes $1B Arbitral Award Against Walgreens

    An advocacy group for the retail industry is backing Walgreens as it looks to set aside a nearly $1 billion arbitral award in a dispute with a COVID test maker, telling a Delaware federal judge that judicial intervention is warranted in this case.

  • May 10, 2024

    No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal

    A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.

  • May 08, 2024

    Fla. Lab Owner Gets 10 Years For Unneeded Medical Tests

    A Florida medical lab owner has been sentenced to 10 years in prison after pleading guilty to charges related to accusations that he billed Medicare for $53 million in unnecessary genetic cancer screening tests.

  • May 07, 2024

    MultiPlan, Insurance Cos. Accused Of Algorithmic Collusion

    A medical provider has lodged a proposed class action in Illinois federal court accusing MultiPlan and major insurance companies, including UnitedHealth, Aetna, Kaiser Permanente and Cigna, of using pricing tools to systematically underpay out-of-network providers.

  • May 07, 2024

    New FDA Device Rule No Cure For Unregulated Lab Tests

    The U.S. Food and Drug Administration's newly claimed authority over lab-developed tests will leave untold numbers of unregulated — and in some cases, inaccurate or otherwise faulty — tests in the hands of clinicians.

  • May 06, 2024

    Hooper Lundy Adds Government Relations Director

    An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.

Expert Analysis

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • How AI May Be Used In Fintech Fraud — And Fraud Detection

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    Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

  • What Recent Study Shows About AI's Promise For Legal Tasks

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    Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

  • BIPA's Statutory Exemptions Post-Healthcare Ruling

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    The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.

  • What's New In FDA's Updated Data Monitoring Guidance

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    The U.S. Food and Drug Administration's new guidance on the use of data monitoring committees in clinical trials is set to replace the agency's 2006 guidance on the topic, with notable updates including stronger language indicating a more stringent stance against financial conflicts of interest and adaptation to recent changes in DMC structure, say attorneys at Hogan Lovells.

  • Keeping Up With Class Actions: Data Breach Litigation In Flux

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    In this monthly look at notable class action decisions, Gerald Maatman at Duane Morris examines a recent mixed-bag data breach ruling from an Illinois federal court — in the context of case law developments over the last year — which illustrates the range of issues confronting litigants going forward.

  • Inside The PTAB's Seagen Cancer Drug Patent Decision

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    The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.

  • Despite Risks, AI Is A Worthy Tool For Healthcare Industry

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    Artificial intelligence appears to provide a productive path forward for the healthcare industry, improving economic and human health outcomes, though companies must continue to address certain technology and compliance pain points, says Sarah Abrams at Bowhead Specialty Underwriters.

  • Potential Defendant Strategies Amid Calif. Privacy Questions

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    Although the current case law surrounding the California Consumer Privacy Act is in its infancy, courts have begun addressing important issues related to the notice-and-cure provisions of the statute, and these decisions show defendant-businesses would be wise to assert their notice rights early and repeatedly, say Viola Trebicka and Dan Humphrey at Quinn Emanuel.

  • Health Policy Legislative Landscape May Remain Frozen

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    With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

  • What Businesses Should Know About NJ Privacy Bill

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    New Jersey’s recently passed comprehensive privacy bill S.B. 332 presents businesses with a nuanced framework and compliance obligations, including opt-in consent requirements for sensitive data, with recommendations for businesses to organize data, review consent requirements and more, says Trisha Sircar at Katten.

  • Staying Ahead Of The AI Policymaking Curve

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    With artificial intelligence poised to be the hottest legislative and regulatory topic in 2024, expect the AI policymaking toolbox to continue to expand and evolve as stakeholders in the U.S. and abroad develop, deploy, use and learn more about these technologies, say attorneys at Hogan Lovells.