Digital Health & Technology

  • March 21, 2024

    Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation

    A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.

  • March 21, 2024

    UpHealth Claims $110M Win In Glocal Control Fight

    Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."

  • March 21, 2024

    Woman Lost Independence Due To Strattice Mesh, Jurors Told

    A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.

  • March 21, 2024

    Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent

    The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.

  • March 18, 2024

    Texas Hospital Loses Bid To Dismiss Patients' Hack Suit

    A Texas federal judge handed a win to the plaintiffs suing a hospital system in the aftermath of a hack that saw hundreds of patients' data pilfered, dismissing some of the claims in the proposed class action but allowing the suit to move forward after a hearing Monday.

  • March 14, 2024

    Health Co. Says Future Harm Risk Falls Short In Breach Suit

    New Jersey healthcare provider Capital Health System urged a Garden State federal judge on Wednesday to toss a proposed class action seeking damages as a result of a 2023 data breach, arguing that the plaintiffs failed to allege their personal identifying information was actually misused.

  • March 13, 2024

    HHS To Investigate Whether Cyberattack Exposed Patient Data

    The U.S. Department of Health and Human Services opened an investigation Wednesday into the cyberattack on Change Healthcare to determine whether the hack exposed patients' confidential data or violated other privacy protections.

  • March 13, 2024

    Hospital Manager Cements $3.5M Gabon Arbitration Award

    The Gabonese Republic must pay a $3.5 million arbitration award obtained by an Austrian healthcare management company, a D.C. federal judge ruled after the central African nation failed to appear in court.

  • March 11, 2024

    Biden Calls For More Cybersecurity Funding Across Agencies

    The Biden administration on Monday pushed Congress to make significant monetary investments in efforts to bolster the federal government's cybersecurity posture, including by earmarking $13 billion to support initiatives across civilian agencies and devoting additional funding to help the U.S. Department of Health and Human Services combat a growing scourge of cyberattacks on healthcare providers. 

  • March 08, 2024

    DOJ Eyes FCPA For New Whistleblower Rewards Program

    U.S. Department of Justice officials on Friday signaled a renewed emphasis on fighting foreign corruption, saying its planned whistleblower rewards program should prove useful in Foreign Corrupt Practices Act cases against private companies, and warned companies against running afoul of new rules barring the sale of personal data to foreign adversaries of the U.S.

  • March 08, 2024

    Colo. DNA Scientist Fudged Data For 650 Cases, Police Say

    A former DNA scientist for the Colorado Bureau of Investigation manipulated data for years, the bureau announced Friday, stating that an investigation has identified more than 650 cases affected since 2008.

  • March 08, 2024

    Ambrose Mills Adds IP Expert From Sterne Kessler In Virginia

    Ambrose Mills & Lazarow PLLC, a corporate and IP boutique, has hired an intellectual property attorney from Sterne Kessler Goldstein & Fox LLP who focuses on patent matters and brings over a decade of experience, Ambrose Mills announced Thursday.

  • March 08, 2024

    Cybersecurity Co. Promotes Attys To GC, Chief People Officer

    Florida-based cybersecurity company ReliaQuest announced it has promoted two of its in-house attorneys to general counsel and chief people officer.

  • March 07, 2024

    Wash. Justices Won't Hear Unions' Wage Clawback Case

    Washington's highest court has rejected three unions' request for justices to decide how private employers may respond when they erroneously overpay employees, clearing the way for a jury to hear the case contesting a healthcare system's wage clawback after its payroll system was hit by a cyberattack.

  • March 07, 2024

    Sens. Tell Stores To Get Illegal E-Cigs Off Their Shelves

    Five U.S. senators on Thursday told the heads of major convenience store and gas station chains to stop sales of unauthorized flavored e-cigarette products, saying that their illegal sales pose a major threat to public health, especially children's.

  • March 07, 2024

    Fed. Circ. Says IP License May Be Part Of Procurement Deal

    The Federal Circuit on Wednesday revived a software developer's claims that the U.S. Food and Drug Administration misappropriated its data, saying the developer had sufficiently alleged it was party to a government contract that allowed lawsuits under the Contract Disputes Act.

  • March 07, 2024

    Moses & Singer Healthcare Atty Joins Day Pitney In Hartford

    Day Pitney LLP has added an experienced attorney to its Hartford office as counsel from Moses & Singer LLP in New York.

  • March 06, 2024

    CBP Details Apple Watch Redesign OK In Masimo Patent Row

    U.S. Customs and Border Protection has released its January decision finding that redesigned Apple Watches do not infringe Masimo Corp.'s blood oxygen monitor patents, explaining that while the new versions can access the patented feature, doing so requires "significant alteration."

  • March 06, 2024

    PTAB Has To Rehear Challenge In Biotech Row

    A panel set up by U.S. Patent and Trademark Office Director Kathi Vidal has told the Patent Trial and Appeal Board it needs to redo its review of a fight between two biotech companies.

  • March 06, 2024

    Corporate Vet Joins Orrick's Tech Group From Wilson Sonsini

    Orrick Herrington & Sutcliffe LLP announced that a former Wilson Sonsini Goodrich & Rosati PC tech attorney with over a decade of in-house experience has joined the firm's technology companies practice as a New York-based partner.

  • March 06, 2024

    Ex-Stimwave CEO Found Guilty Of Healthcare Fraud

    A New York federal jury on Wednesday convicted the former CEO of Stimwave over allegations that the medical device maker sold an implant for chronic pain sufferers with a bogus component in order to drive up billings.

  • March 05, 2024

    Gibson Dunn AI Leader On Weathering The AI Policy Blizzard

    Like a mountaineer leading a team through a snowstorm, Gibson Dunn & Crutcher LLP's artificial intelligence co-chair Cassandra L. Gaedt-Sheckter is guiding companies developing and using artificial intelligence through a blizzard of new laws and regulations coming online in Europe and the U.S., saying that assessing AI risks is the North Star to mitigating them.

  • March 05, 2024

    Liberty Unit Off Hook For Sleep Machine Cleaner Class Action

    A Liberty Mutual unit needn't defend a manufacturer of cleaning devices for sleep machines in a multidistrict class action alleging that the company falsely advertised its products as safe and healthy, a New Hampshire federal judge ruled, finding the underlying action lacks any claim for damages covered under the policies.

  • March 05, 2024

    IP Litigation Vet Joins Wiggin and Dana's NY Office From LTL

    Wiggin and Dana LLP said Tuesday that it is welcoming a technology and life sciences expert from litigation boutique LTL Attorneys LLP to its intellectual property litigation group.

  • March 05, 2024

    DLA Piper Adds Merck SVP As New Life Sciences Sector Chair

    An experienced in-house attorney with a longtime passion for life sciences and medicine has left her position as a C-suite executive at biopharmaceutical giant Merck to join DLA Piper as the chair of its life sciences sector.

Expert Analysis

  • Writing Thriller Novels Makes Me A Better Lawyer

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    Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

  • White House Activity Is A Band-Aid For Regulating AI In Health

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    In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

  • How Legal Teams Can Prep For Life Sciences' Tech Revolution

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    The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

  • Life Sciences Regulators Must Write Cloud-Specific Guidance

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    As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.

  • 3 Tips For Defending Against Data Breach Litigation

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    As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.

  • What Pharma Cos. Must Know About FDA Off-Label Guidance

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    The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.

  • It's Time To Prescribe Frameworks For AI-Driven Health Care

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    As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.

  • FDA Proposals Clarify Rules For Devices With Predicates

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    As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.

  • How Int'l Regulatory Collabs Can Expedite Pharma Approvals

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    Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.

  • Why Standing Analysis Is Key In Data Breach Mediation

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    Amid a growing wave of data breach class action litigation, recent legal developments show shifting criteria for Article III standing based on an increased risk of future identity theft, meaning parties must integrate assessments of standing into mediation discussions to substantiate their settlement demands in data breach class actions, says Abe Melamed at Signature Resolution.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • FDA's Lab-Developed Test Rule Faces High Hurdles

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    The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.