Digital Health & Technology

  • 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.

  • February 29, 2024

    Medtronic Expands Its Bladder Device Patent Fight

    Medical device conglomerate Medtronic has opened two more fronts in its fight over a new kind of "neuromodulation solution" for bladder and bowel control issues that's at the center of its ongoing intellectual property dispute with a newer and smaller rival, a recent acquisition of Boston Scientific.

  • February 29, 2024

    UnitedHealth Unit Says Blackcat Group Behind Cyberattack

    A UnitedHealth unit on Thursday announced that the "Blackcat" ransomware group is behind a cyberattack that has taken out its information technology systems and services for the past nine days.

  • February 29, 2024

    Medtronic Says 3 Years Of Tax Returns Under IRS Audit

    Three years of medical device company Medtronic's federal income tax returns are being audited by the Internal Revenue Service, the company said in a U.S. Securities and Exchange Commission filing.

  • February 28, 2024

    Biotech Co., Ex-Exec And Investor To Pay $5.2M In SEC Suit

    A New York federal judge entered final judgments against medical device company RenovaCare, its controlling shareholder, and its former chief operating officer to settle a U.S. Securities and Exchange Commission suit accusing them of artificially inflating RenovaCare's stock price, ordering them to pay a total of $5.2 million.

  • February 28, 2024

    Attys Get $750K Fee Award In $6M Med Tech Co. Deal

    Class attorneys for minority shareholders of Autonomous Medical Devices Inc. who secured a $6 million settlement to resolve claims about a purportedly underpriced stock sale to an interest of Oracle founder Larry J. Ellison won court approval of the settlement Wednesday, along with a requested $750,000 fee award.

  • February 28, 2024

    WilmerHale Adds Ex-Medtronic Legal Leader To Its DC Office

    WilmerHale has hired for its Washington, D.C., office an attorney who helped build the global trade legal department at healthcare technology company Medtronic.

  • February 28, 2024

    Dexcom Rival Fights Its Bid To Tweak Glucose Monitor Patent

    A Korean medical tech company has asked a London court to block Dexcom's bid to tweak its diabetes management patent to avoid losing protections should the court rule that it's invalid.

  • February 28, 2024

    NuVasive Can Pierce Co. To Collect From Ex-Rep, Judge Says

    NuVasive Inc. can pierce the corporate veil to collect a $617,000-plus arbitration judgment it won against a company operated by one of its former sales representatives who improperly cut ties with the medical device company and violated his noncompete agreement, a Boston federal judge has ruled. 

  • February 27, 2024

    Last-Minute Settlement Stops 2nd Catheter Trial In Del.

    A second legal fight over patents that cover a type of external catheter for women will not be going before a jury in Wilmington after the two feuding rivals agreed on Tuesday to settle the dispute.

  • February 27, 2024

    10th Circ. Backs FDA E-Cigarettes Marketing Denial

    The Tenth Circuit on Tuesday upheld the U.S. Food and Drug Administration's denials of two companies' applications to market flavored e-cigarettes, rejecting their argument that the agency secretly planned to reject any applications without long-term studies.

  • February 27, 2024

    Survey Finds Just 4 in 10 Healthcare Orgs. Review AI Guidance

    Only 40% of healthcare professionals surveyed by the Berkeley Research Group say their organizations are reviewing or plan to review regulatory guidance on artificial intelligence, even as they expect rapid growth in AI deployment over the next three years, according to a report released Tuesday.

  • February 26, 2024

    NC Health Data Breach Class Deal Gets Preliminary OK

    A North Carolina state judge has preliminarily approved a settlement resolving a class action against an orthopedic practice over a data breach that compromised sensitive personal information and medical records of current and former patients.

  • February 26, 2024

    UnitedHealth Unit Hits 6th Day Of IT Outage After Cyberattack

    A UnitedHealth Group unit on Monday entered its sixth day of dealing with a cyberattack that breached its information technology systems and services spanning pharmacy claims billing, medical records and payor communications software.

  • February 26, 2024

    NC Hospital's Weak Data Security Led To Breach, Suit Says

    A patient filed a proposed class action in North Carolina's business court alleging a hospital system's inadequate data security resulted in a breach that allowed hackers to access private personal and health information.

  • February 23, 2024

    Seattle Hospital Gets Facebook Browser Tracking Suit Tossed

    A Washington state judge sided with Seattle Children's Hospital on Friday, throwing out a proposed class action accusing the healthcare provider of privacy law violations and agreeing the group of parents hadn't shown how the use of a browser tracking tool on its website disclosed confidential patient information to Facebook.

  • February 23, 2024

    Chamber's Report Bemoans Biden's March-In Idea For Drug IP

    The most powerful business lobbying group in the U.S. said that although the country ranked at the top of its annual International IP Index, the Biden administration's efforts to potentially use patent laws to reduce the price of pharmaceuticals would jeopardize its place down the line.

  • February 23, 2024

    Fla. Doctor Says T-Mobile Let Hacker Steal Her SIM Card

    A Tampa, Florida, doctor has sued T-Mobile for allegedly failing to stop a "SIM swap" hacker from transferring her personal phone account and then doing little to address the identity theft that followed, which involved the hacker trying to steal thousands from her retirement account and using her medical credentials to write more than 700 fraudulent prescriptions.

  • February 23, 2024

    Healthcare AI Startup Abridge Raises $150M

    AI clinical documentation company Abridge said on Friday that it had raised a $150 million series C round to build on its existing product lines and accelerate research and development.

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.