Digital Health & Technology

  • May 23, 2025

    Seattle Cancer Center Inks $11.5M Class Data Breach Deal

    A Washington state judge has given final approval to an $11.5 million class action settlement to end litigation against Seattle-based Fred Hutchinson Cancer Center over a 2023 data breach that exposed patient information, with the judge awarding $3.8 million in attorney fees in a deal class counsel values at more than $50 million.

  • May 22, 2025

    Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court

    Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.

  • May 20, 2025

    Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit

    A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.

  • May 20, 2025

    Medical Organizations Sue Feds For Removing Health Data

    The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.

  • May 20, 2025

    Biotech Stockholders Challenge Director Pay Levels In Del.

    Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.

  • May 20, 2025

    Sales Exec Admits Role In $70M Brain Scan Kickback Scheme

    A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.

  • May 20, 2025

    NYU Langone IT Workers Get Conditional Cert. In Wage Suit

    Information technology workers who accused New York University's academic medical center of improperly classifying them as exempt from earning overtime wages can proceed as a collective, a federal judge ruled, finding they showed they were all subject to the same pay policies and practices.

  • May 20, 2025

    Foreign Drugmakers Brace For More Visits Amid FDA Cuts

    The U.S. Food and Drug Administration's plan to expand surprise inspections of overseas drug manufacturing plants is a legitimate enforcement threat that should be taken seriously, even as the agency adjusts to a future with a smaller workforce.

  • May 16, 2025

    Surgical Center Operator Inks $15M Deal Over Data Breach

    Shields Health Group Inc., which runs dozens of MRI and surgical centers around New England, has agreed to pay around $15 million to resolve claims in a proposed class action stemming from a data breach that compromised the personal information of over 2 million people.

  • May 15, 2025

    Zuckerberg Can't Avoid Deposition In Meta Health Privacy Suit

    A California federal judge on Wednesday refused to rethink her earlier order forcing Meta CEO Mark Zuckerberg to give a limited deposition in privacy litigation over a Facebook tool's alleged collection of patient health information, rejecting Meta's arguments that other executives are better suited to testify.

  • May 14, 2025

    Health Co. Founder Pleads Guilty In $5M Fraud Case

    A Florida man who operated a health monitoring company geared toward keeping substance-addicted people from relapsing has admitted to bilking investors out of $5 million by misstating interest in the firm, the U.S. attorney's office in Philadelphia said.

  • May 14, 2025

    Virta Health's Diabetes Mission Is Personal For Its GC

    Jamie Anderson said it's important to find a mission-driven company to join — and when that mission aligns with an attorney's personal life, it's even more inspiration to work hard and contribute to the success of the business.

  • May 13, 2025

    Becton Dickinson Sues Baxter Over Infusion Pump Patents

    Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.

  • May 13, 2025

    4 Firms Seek $5M In $6.75M Seattle Hospital Web Privacy Deal

    An unnamed plaintiff is urging a Washington state judge to give final blessing to an up to $6.75 million settlement to end allegations that a Seattle hospital system deployed source code on its website that divulged patients' private health information to Google and Facebook, with class counsel requesting another $5 million in fees.

  • May 13, 2025

    Split PTAB Cites SAS To Reject Samsung Petition

    The Patent Trial and Appeal Board will not review whether a real-time interpretation patent for those hard of hearing is invalid after finding that only a quarter of Samsung's challenge could be successful, which isn't worth the full trial mandated by the U.S. Supreme Court.

  • May 13, 2025

    Telehealth Coalition Director Talks Abortion Drug Battles

    Since the overturning of Roe, abortion medications have become the most common method in the U.S. of ending a pregnancy. A co-founder of the Abortion Coalition for Telemedicine talks about the new legal battles over mifepristone, state shield laws, and a colleague facing criminal charges for sending abortion drugs through the mail.

  • May 13, 2025

    Former J&J, Moderna Exec Joins Goodwin Procter In Boston

    Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.

  • May 12, 2025

    Will Justices Finally Rein In Universal Injunctions?

    The U.S. Supreme Court is expected to address for the first time Thursday the propriety of universal injunctions, a tool federal judges have increasingly used to broadly halt presidential orders and policy initiatives, and whose validity has haunted the high court's merits and emergency dockets for more than a decade.

  • May 12, 2025

    AI Powers Next Wave Of Telehealth M&A After 2024 Uptick

    Telemedicine-focused deal activity is poised for a transformative shift in 2025 as strategic buyers increasingly seek companies that embed artificial intelligence across their platforms, according to a new report from tech investment bank Drake Star.

  • May 07, 2025

    FDA Gets Win In Eli Lilly Weight Loss Drug Shortage Fight

    A Texas federal judge on Wednesday refused to reverse a U.S. Food and Drug Administration decision to remove Eli Lilly & Co.'s popular weight loss drug from a national shortage list, denying a request from pharmacies that produce copycat doses of the drug and entering judgment in favor of the FDA.

  • May 07, 2025

    Masimo Unloads Embattled Audio Unit In $350M Sale

    Samsung Electronics subsidiary Harman International has agreed to acquire Masimo Corp.'s consumer audio division, Sound United, for $350 million in cash, with Masimo taking a financial hit on the business it acquired three years ago for about $1 billion. 

  • May 05, 2025

    High Court Won't Hear Challenge To Miss. Ban On Pot Ads

    The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.

  • May 02, 2025

    Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant

    Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.

  • May 01, 2025

    DaVita Hit With Class Actions Over Ransomware Attack

    DaVita Inc. is facing at least two proposed class actions over a data breach the kidney care provider announced in April, with current and former patients alleging Wednesday in Colorado federal court that data thieves have already engaged in identity theft and fraud while DaVita has yet to offer details.

  • May 01, 2025

    US Tells Justices Telemedicine Case Isn't Ideal For Eligibility

    The Justice Department is urging the U.S. Supreme Court to reject a petition over the eligibility of telemedicine patents it's accused of infringing, but it said that if the petition is granted, it plans to argue the patents shouldn't have been invalidated as abstract.

Expert Analysis

  • 5 Data Privacy Practices Cos. Should Implement Now

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    Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.

  • Privacy Lessons From FTC's BetterHelp Consent Decree

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    The Federal Trade Commission's recent enforcement action against BetterHelp highlights the growing risk associated with the use of third-party cookies and pixels on websites for companies that offer health services, say Rachel Marmor and Shannon Hartsfield at Holland & Knight.

  • 118th Congress: Investigative Priorities And Rule Changes

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    Attorneys at Gibson Dunn lay out what companies and individuals can expect with regard to congressional investigations in the 118th Congress, from political priorities to new rules and authorities.

  • Emerging Trends In Electronic Health Record Enforcement

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    As electronic health record systems become increasingly ubiquitous in health care, recent Anti-Kickback Statute and False Claims Act cases involving EHR systems provide a helpful list of issues that tech-savvy relators and government investigators might identify, say Ellen London at London & Stout and former Assistant U.S. Attorney Li Yu.

  • FTC's GoodRx Action Highlights Risks For Digital Health Cos.

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    The Federal Trade Commission's first-of-its-kind enforcement action against GoodRx for unlawfully sharing sensitive customer information is indicative of regulators' growing interest in the digital health space and heightens the importance of taking proactive compliance steps, say attorneys at Ropes & Gray.

  • What DOJ's 2022 Recovery Stats Say About FCA Enforcement

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    Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.

  • Medicare Developments Ahead For Remote Health Monitoring

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    Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.

  • Calif. Privacy Law Holds Implications For Mental Health Apps

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    California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.

  • New Clinical Trial Law Promotes Diversity And Modernization

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    The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.

  • Evaluating The Legal Ethics Of A ChatGPT-Authored Motion

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    Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.

  • 2022 Law And Policy Highlights In Digital Health Care

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    This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.

  • Next Compliance Steps For Health Cos. Using Tracking Tech

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    In light of the U.S. Department of Health and Human Services Office for Civil Rights' expansive view of what constitutes protected health information, regulated entities seeking to provide websites and mobile apps for patients may need to choose between several imperfect compliance pathways if they wish to continue using tracking technologies, say attorneys at Ropes & Gray.

  • Top Trends And Challenges For Health Care Financing In 2022

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    Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.