Digital Health & Technology

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Predatory Medicare Marketing Faces Regulator Pushback

    Consumers weighing Medicare plan options should have greater protections from predatory marketing and sales tactics, thanks to a new rule by the Centers for Medicare & Medicaid Services that was finalized April 4.

  • April 08, 2024

    Doctors Say MSU Vax Mandate Suit Needs High Court Review

    Three doctors urged the U.S. Supreme Court to take up a case challenging Michigan State University's vaccine mandate after the Sixth Circuit backed the suit's dismissal, arguing that the circuit court should have applied a stricter standard when considering whether the government could interfere with patients' medical decisions.

  • April 04, 2024

    5th Circ. Scrutinizes Data-Tracking On La. Health Provider Site

    A Fifth Circuit panel questioned Louisiana health care providers Thursday on the use of "tracking pixels" on their website, asking counsel for the providers whether a third party like Facebook could access patient records without patient permission.

  • April 04, 2024

    Microsoft Unit Gets Fed. Circ. Alice Win On Imaging Patents

    The Federal Circuit on Thursday gave a win to a software company acquired by Microsoft for nearly $20 billion, affirming a decision that claims in four medical imaging patents it was accused of infringing are invalid for claiming only an abstract idea.

  • April 04, 2024

    Ga. OB-GYN Office Hit With Data Breach Class Action

    An Atlanta OB-GYN practice has been hit with a class action in Georgia federal court over a January data breach that allegedly impacted the personal and protected health information of tens of thousands of patients.

  • April 03, 2024

    Microsoft Notches Fed. Circ. Win In 3D Imaging Patent Fight

    The Federal Circuit on Wednesday backed a ruling from an administrative tribunal that wiped out most of a patent issued to a Florida radiologist and his ex-Lockheed Martin business partner, whose company is suing Microsoft over its line of HoloLens AR headsets.

  • April 02, 2024

    Mind Your Business: Wash. Privacy Law Ignites National Prep

    Companies far beyond the borders of Washington are taking stock of what customer data they're collecting — and what it might reveal — as they face compliance with the state's expansive new privacy law.

  • April 02, 2024

    Healthcare Deals This Week: Moderna, Hildred And More

    From a private equity fundraise worth hundreds of millions of dollars to a new life sciences IPO, the healthcare industry saw a handful of news-making deals this past week.

  • April 02, 2024

    Ga. Children's Hospital Accused Of Mining Patient Data

    A major Georgia pediatric healthcare system has been using web data trackers to illegally transmit confidential patient data to Facebook and other companies to boost its bottom line, according to a proposed class action filed in the Peach State on Tuesday.

  • March 29, 2024

    4th Circ. Revives Data Breach Suit Against Medical Center

    The Fourth Circuit on Friday revived a proposed class action alleging that Sandhills Medical Foundation Inc. failed to protect the personal information of patients whose data was leaked following a cyberattack, saying the health care provider is not shielded under federal immunity and that the government cannot be substituted as a defendant.

  • March 28, 2024

    White House Directs Agencies To Install AI Risk Safeguards

    The White House on Thursday issued a new directive requiring all federal agencies to address safety and civil rights risks in their use and procurement of artificial intelligence in an array of settings, including conducting screenings at airports and making decisions affecting Americans' healthcare, employment and housing.

  • March 26, 2024

    Meet The Calif. Atty Taking On Health Insurers' Use Of AI

    With the health insurance industry under scrutiny over its use of algorithms and artificial intelligence in the patient coverage review process, California appellate attorney Glenn Danas saw an opening for litigation with what he calls a "high outrage factor."

  • March 26, 2024

    Healthcare Hack May Be Wake-Up Call For Industry And Gov't

    The recent cyberattack that sabotaged vital billing and prescribing services operated by a UnitedHealth unit that processes roughly half the medical claims in the U.S. has highlighted the urgent need for providers in this critical sector to not only understand supply chain security risks, but also to work more closely with the federal government to combat these threats.

  • 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.

Expert Analysis

  • Life Sciences Regulators Must Write Cloud-Specific Guidance

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.