Digital Health & Technology

  • 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.

  • March 04, 2024

    WTO Conference Ends Without COVID IP Waiver Expansion

    The World Trade Organization did not reach an agreement at a conference last week on a proposal to expand a waiver on intellectual property for COVID vaccines to cover tests and treatments, a move welcomed by opponents of the plan.

  • March 04, 2024

    Trial Of Ex-Stimwave CEO Over Medical Device Nears End

    Prosecutors on Monday urged a Manhattan federal jury to convict the former CEO of Stimwave Technologies for hawking a medical device for chronic pain sufferers with a bogus component designed to drive up billings, while defense counsel derided a lack of evidence to support the government's claims.

  • March 04, 2024

    French Spinal Care Co. Can't Get €4.2M Award Enforced

    A Delaware judge has blocked the enforcement of a €4.2 million ($4.56 million) arbitral award issued in a dispute over failed plans for a French medical equipment company to expand into Colombia, ruling that the company misinterpreted an arbitration clause that referred to a nonexistent arbitral forum.

  • March 01, 2024

    Gov't Says AI Patent Gap Between US And China Is Growing

    A report by a U.S. federal agency says that people living in China have been granted more patents than people living in the U.S., and the latest figures suggest an especially widening gap in patents issued over artificial intelligence.

  • March 01, 2024

    LGBTQ+ Org. Seeks To Ward Off Paxton's Documents Demand

    An LGBTQ+ advocacy group has sued Texas Attorney General Ken Paxton and his office over a civil investigative demand for documents in connection with a state law banning gender-affirming care for transgender youths, saying the demand violates the organization's and its members' constitutional rights.

  • March 01, 2024

    Cannabis Consulting Co. Says Clinic Owes $101K On Contract

    A laboratory and consulting firm that focuses on the cannabis industry alleged that a Michigan clinic owes the firm more than $100,000 for unpaid services, according to a lawsuit filed in Colorado federal court.

  • March 01, 2024

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen a legal battle between confectionary heavyweight Mars Wrigley UK and a frozen food manufacturer, a trademark infringement claim by Abbott Diabetes Care over glucose monitoring meters, Mercedes-Benz Group hit with two commercial fraud disputes, and the Mediterranean Shipping Company tackle a cargo claim by an insurance company. Here, Law360 looks at these and other new claims in the U.K.

Expert Analysis

  • 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.

  • FDA's Drug Software Draft Guidance Raises New Questions

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    The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.

  • A Topic-Based Analysis Of FDA Responses To FOIA Requests

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    By using a topic modeling method, it's possible to discern the major recurring topics in Freedom of Information Act requests made to the U.S. Food and Drug Administration, as well as the likelihood of success for individual topics, says Bradley Thompson at Epstein Becker.

  • State Privacy Laws: Not As Comprehensive As You May Think

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    As more U.S. states enact privacy laws, companies must be aware that these laws vary in scope and content, meaning organizations should take a stringent approach to compliance by considering notice, choice and data security obligations, among other requirements, says Liisa Thomas at Sheppard Mullin.

  • Concerns For 510(k) Sponsors After FDA Proposes Major Shift

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    While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.

  • Address The Data Monopoly, Otherwise Tech Giants Control AI

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    It is likely that we will experience a severe monopoly on artificial intelligence systems and patents by the largest players in the tech industry, so the way we treat data needs to change, whether through the legislature, the courts or tech companies, says Pranav Katti at Barclay Damon.

  • Companies Must Dig Up Old Laws To Stay Privacy-Compliant

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    Despite the recent focus on new privacy and data security laws, companies cannot ignore existing rules that have recently been revived, amended or reinterpreted to address emerging privacy and data security challenges, says Julia Kadish at Sheppard Mullin.

  • 8 Ways Life Sciences Cos. Can Adapt To The Social Media Era

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    As pharmaceutical and medical device companies harness the powerful promotion potential of social media, they must navigate legal, regulatory and reputational risks that can be particularly challenging due to the complex framework of rules that apply to the life sciences industry, say attorneys at Troutman Pepper.

  • HHS Neuromonitoring Advisory May Have Broad Relevance

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    The Health Department Office of Inspector General's recent advisory opinion rejecting a neuromonitoring service's proposal for a shell arrangement isn't surprising, but it could be a harbinger of more warnings against problematic joint venture arrangements to come, says Mary Kohler at Kohler Health Law.