Digital Health & Technology

  • 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.

  • May 03, 2024

    Ala. High Court Won't Rethink Decision On Frozen Embryos

    The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.

  • May 02, 2024

    Walgreens Fights $1B Arb. Award Over COVID Test Contract

    At-home lab test maker Everly Health urged a Delaware federal judge to affirm its nearly $1 billion arbitration award against Walgreens over claims the pharmacy chain deliberately misused the digital health platform's trademark while secretly diverting COVID-19 tests to its own pharmacists while Walgreens argued the arbitrator overstepped his authority in bestowing such an "egregious" award.

  • May 02, 2024

    Masimo Hit With Derivative Suit Over Audio Co. Acquisition

    The top brass at medical device company Masimo Corp. has been hit with a shareholder derivative action claiming they harmed the company and "confused" investors by pushing through a $1 billion acquisition of an audio equipment company, allegedly causing a steep drop in stock prices and a $5.1 billion market capitalization loss.

  • May 02, 2024

    Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.

    Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.

  • May 01, 2024

    Sens. Slam UnitedHealth's Security Lapses, Breach Response

    UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.

  • April 30, 2024

    What's Behind the Q1 Digital Health Funding Rebound

    The digital health industry saw a resurgence in funding at the start of 2024, driven by a handful of mega-rounds and growing deal sizes across the board, but it also faced record-low deal counts as investors signaled pickier attitudes over which ventures they're choosing to fund.

  • April 30, 2024

    Patients Sue NC Plasma Donation Co. Over Data Breach

    A plasma collection company has been hit in North Carolina federal court with at least two proposed class actions as of Monday claiming it failed to safeguard patient data, resulting in a breach in which names, Social Security numbers, addresses and treatment information were allegedly exposed by hackers.

  • April 30, 2024

    Tougher Privacy Rule Won't End Abortion Data Fight

    Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.

  • April 29, 2024

    UnitedHealth's Cyberattack Response Is 'Inadequate,' AGs Say

    Nearly two dozen state attorneys general urged UnitedHealth Group and its subsidiary Change Healthcare "to do more" to address the fallout from a February cyberattack by Russian ransomware group Blackcat that breached their systems and services, noting their response efforts to the outage "have been inadequate."

  • April 29, 2024

    Amid Backlash, FDA Extends Control For Lab-Developed Tests

    The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.

Expert Analysis

  • 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.

  • The 7th Circ.'s Top 10 Civil Opinions Of 2023

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    Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

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    In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

  • Uncharted Waters Ahead For FCA Litigation In 2024

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    Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

  • Healthcare Industry Must Prepare For Greater AI Regulation

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    Healthcare entities that use even basic machine-based systems should pay close attention to a recent executive order and a proposed bill, both of which focus on artificial intelligence safety and security, and signal the government's intent to establish a regulatory framework for AI-enabled technology, says Kristen Petry at Spencer Fane.