Digital Health & Technology

  • March 25, 2024

    Ga. Judge Slams Attys Over 'Incredible' House Arrest Request

    A Georgia federal judge on Monday postponed the sentencing of a cybersecurity contractor convicted of hacking into a hospital's computer systems after tearing into his attorneys over their request for nearly five years of home confinement instead of prison, for which the judge found "no basis."

  • March 22, 2024

    $900M Trade Secrets Case Against Kaiser Foundation Flops

    A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.

  • March 22, 2024

    Final OK Sought For Economic Loss Deal In CPAP Recall MDL

    Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.

  • March 22, 2024

    LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial

    New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.

  • 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.

Expert Analysis

  • 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.

  • For Radiation Oncology Units, Cyber Vigilance Is Crucial

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    Recent cyberattacks highlight the unique cybersecurity challenges faced by radiation oncology departments and the importance of implementing policies and procedures to safeguard operations and patient data, says Paul Schmeltzer at Clark Hill.

  • How Merger Review Overhaul Could Affect Health Industry

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    For those in the health care industry considering growth and expansion strategies, the antitrust agencies' recent proposals for new Hart-Scott-Rodino rules and more complex merger guidelines will increase deal timelines, the merging parties' burden, and overall uncertainty and potential antitrust risk as to the outcome, say attorneys at Husch Blackwell.

  • What Circuit Split May Mean For FCA Kickback Liability

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    The recent circuit split on the meaning of the resulting-from provision in False Claims Act kickback cases could have significant ramifications for FCA liability, as it could affect the standard of causation that plaintiffs must meet to establish liability, say former federal prosecutors Li Yu, Ellen London and Gregg Shapiro.

  • How Health Cos. Can Brace For Tracking Tech Scrutiny

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    A joint letter sent by the U.S. Department of Health and Human Services Office for Civil Rights and Federal Trade Commission last month highlights the agencies' concerns about tracking technologies, and may foreshadow a spike in enforcement actions, say attorneys at Moses Singer.

  • Unpacking CMS' Latest Proposals For Telehealth Flexibilities

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    The Centers for Medicare and Medicaid Services' calendar year 2024 proposed rule includes a number of important extensions to telehealth flexibilities, acknowledging the importance of these temporary policies, but permanent certainty will require further legislative action and agency rulemaking, say attorneys at Baker Donelson.