Digital Health & Technology

  • January 05, 2024

    Eli Lilly Goes Straight To Consumers With Telehealth Platform

    A new website launched by Eli Lilly & Co. will connect patients with doctors who treat obesity and offer direct home delivery of the company's obesity drug Zepbound, which the U.S. Food and Drug Administration approved in November.

  • January 05, 2024

    Split 9th Circ. Revives Antitrust Suit Against Catheter Maker

    A split Ninth Circuit panel sided with Innovative Health LLC on Friday and revived its antitrust suit against Biosense Webster Inc. in a dispute over the market for catheters, saying Innovative provided sufficient evidence to defeat summary judgment in its claim that Biosense tied the sale of catheters to clinical support services.

  • January 05, 2024

    Barley Snyder Promotes Health, Estate Attys To Partnership

    Barley Snyder has announced the addition of an experienced healthcare lawyer and an expert estate planner as its first new partners of the year.

  • January 05, 2024

    Ga. Board Restores Telehealth Rx For Controlled Substances

    A Georgia medical oversight group has relented and restored doctors' ability to prescribe controlled substances, including painkillers and attention-deficit medications, via virtual visits.

  • January 05, 2024

    IQVIA Drops Healthcare Ad Deal After Court Pause

    Healthcare data company IQVIA has abandoned its planned purchase of Propel Media after the Federal Trade Commission convinced a court to pause the deal over concerns about the cost of advertising that targets doctors and other healthcare professionals.

  • January 04, 2024

    Birth Control Clips Hurt Women When They Move, Suit Says

    The Filshie Clips birth control device may move around after implantation, a hazard the clips' manufacturers did not warn the public or healthcare professionals about, according to a Connecticut federal lawsuit from a woman who says she was injured by them.

  • January 04, 2024

    Merck And Insurers Settle $1.4B Cyberattack Coverage Case

    Merck has reached a settlement with its insurers over whether the pharmaceutical giant's "all-risk" property insurance covered $1.4 billion in losses stemming from the 2017 NotPetya attack or if its "hostile/warlike" exclusion applies.

  • January 03, 2024

    AHA Says Data-Blocking Penalty Threatens Rural Hospitals

    A proposed federal rule that establishes monetary penalties for information blocking may threaten the financial viability of small and rural hospitals, according to the American Hospital Association.

  • January 03, 2024

    ACTS Retirement Data Breach Suit Settlement Gets Initial OK

    A Pennsylvania federal judge gave preliminary approval Tuesday to a deal inked by ACTS Retirement Services Inc. to settle claims it failed to protect the personal information of nearly 21,000 people exposed in an April 2022 data breach.

  • January 03, 2024

    BioXcel Execs Face Investor Suit Over Alzheimer's Drug Probe

    Top brass at artificial intelligence-driven biopharmaceutical company BioXcel Therapeutics Inc. have been hit with a shareholder derivative suit alleging they took too long to disclose a U.S. Food and Drug Administration probe of its development of an Alzheimer's treatment and its lead clinical trial investigator's compliance issues.

  • January 03, 2024

    FDA Seeks Comment On Ideas To Improve Agency Guidance

    The U.S. Food and Drug Administration asked pharmaceutical companies, healthcare providers and others Wednesday to weigh in on how the agency can more quickly provide guidance on its interpretation of federal laws and regulations.

  • January 02, 2024

    Colo. Doctor Says Biz Partner Stole Software For Own Co.

    A Colorado doctor filed a lawsuit Tuesday against his former business partner over a failed medical software startup, alleging the business partner developed a competing platform and diverted revenue from the shared startup to his own company.

  • January 02, 2024

    Lawsuit Says 23andMe Dragged Its Feet In Data Leak

    A proposed class action in California federal court claims ancestry tracking company 23andMe took too long to respond to a data breach that affected millions of customers and targeted Ashkenazi Jewish users.

  • January 02, 2024

    Chancery Dissolves Biomed Co. For 'Egregious' Conduct

    Delaware's chancellor has ordered the dissolution of a company whose CEO and founder "lied, cheated, destroyed evidence and repeatedly ignored court orders" in a dispute pitting one brother against another over repayment of a $1.8 million loan for purportedly "Nobel Prize-worthy" biomedical research.

  • January 01, 2024

    Sunset Of CMS' Remote Supervision Policy Draws Concern

    As part of their New Year's resolutions, some leaders at U.S. healthcare associations are planning to push the federal government to restore a policy that allowed teaching physicians to remotely supervise residents as they care for Medicare patients in every part of the country.

  • December 28, 2023

    Apple Watch Import Ban Put On Hold By Fed. Circ.

    The Federal Circuit on Wednesday temporarily suspended a U.S. International Trade Commission ruling that banned imports of the Apple Watch in a patent dispute with Masimo Corp.

  • December 26, 2023

    White House Won't Veto ITC Apple Watch Import Ban

    The Biden administration said Tuesday that it will not veto a U.S. International Trade Commission decision banning imports of the Apple Watch in a patent dispute with Masimo Corp., days after the tech giant stopped selling some models of the popular devices due to the ruling.

  • December 21, 2023

    5th Circ. Urged To Reject Retrial In DOJ's $140M Fraud Suit

    A former medical device sales representative accused of running a $140 million healthcare fraud scheme in Houston with four other men told the Fifth Circuit on Thursday that he shouldn't be forced to face a retrial, writing that the government "knew or should have known" about alleged prosecutorial misconduct that forced a mistrial the first time around.

  • December 21, 2023

    Becton Investors Seek OK Of $85M Deal Over Alaris Recall

    A class of Becton Dickinson investors asked a New Jersey federal judge Thursday for his initial blessing on an $85 million settlement resolving securities fraud claims that the medical technology maker hid looming regulatory setbacks affecting the sales of its Alaris infusion pump, which Becton voluntarily recalled in 2020.

  • December 21, 2023

    Top Government Contracts Of 2023: A Year In Review

    This year saw the federal government conclude a $60 billion IT program for the U.S. Department of Veterans Affairs and a previously stalled $5.7 billion enterprise technology deal for the U.S. Air Force. But fatal errors with the VA's new $16 billion health records system forced it to pause the program. Here, Law360 takes a look back at some of the biggest government contracts from 2023.

  • December 21, 2023

    Top North Carolina Cases Of 2023

    A newly elected Republican majority on North Carolina's Supreme Court came out swinging early in 2023, overturning a decision by the previous year's liberal regime that held the state's election maps were gerrymandered and unconstitutional.

  • December 20, 2023

    11 Deals That Shaped Healthcare And Life Sciences In 2023

    The healthcare industry's appetite for mergers and acquisitions waned considerably this year, with both the number and size of deals falling well short of recent years. But that didn't make for a slow 2023, with segments like hospital systems showing renewed activity and major announcements in biotech that signaled a careful but growing appetite from the biggest players.

  • December 20, 2023

    ITC Rejects Apple's Bid To Put Apple Watch Ban On Hold

    The U.S. International Trade Commission on Wednesday denied Apple's request to stay an order that will soon halt imports of Apple Watch models found to infringe Masimo Corp. patents, unless it is vetoed by the White House.

  • December 20, 2023

    FDA Offers Guide On Real-World Data For Device Submissions

    Guidance from the U.S. Food and Drug Administration aims to clarify how the agency assesses real-world data and evidence when considering medical devices submitted for approval, addressing the use of data from wearable devices, among other issues.

  • December 20, 2023

    Stimwave Buyer Can Enforce Sale In 'Disturbing' Domain Row

    The buyer of Stimwave Technologies can force the medical device company's former CEO and her family to relinquish control of a domain name used to direct patients to information about faulty implants, a Delaware bankruptcy judge said Wednesday, calling the family's alleged efforts to redirect web traffic "immoral."

Expert Analysis

  • DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

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    The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.

  • Digital Health Cos. Should Expect More Scrutiny Amid Growth

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    As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.

  • Anti-Kickback Circuit Split Holds Implications For Defendants

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    The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.

  • Post-Dobbs HHS Guidance Brings Privacy Considerations

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    The U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, and ensuing guidance from the U.S. Department of Health and Human Services, will create new privacy compliance issues for health care providers and other companies collecting personal information concerning the use of reproductive health services, say attorneys at Ropes & Gray.

  • HHS Fraud Alert Is A Major Warning To Telehealth Industry

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    The U.S. Department of Health and Human Services recently issued a rare fraud alert, indicating potential changes in telemedicine enforcement, and suggesting that digital health entities are likely to face subpoenas, civil investigative demands and other inquiries, say attorneys at Hooper Lundy.

  • FDA Medical Device Cyber Guidance Protects Patients, Cos.

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    By carefully following the U.S. Food and Drug Administration regulations on cybersecurity for medical devices — including its latest guidance on premarket submissions — and anticipating, tracking and fixing vulnerabilities, manufacturers can reduce risks to patients, as well as their own risks of product liability and data breach claims, say attorneys at Dechert.

  • The State Of Digital Health Care's Pandemic Transformation

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    Two years into the COVID-19 pandemic, tech companies are helping to drive the health industry's transition into a new era of greatly expanded digital health and remote care, though some new challenges involving system compatibility and cybersecurity have arisen as well, says Carter Gage at Sheppard Mullin.

  • Readying Cybersecurity Protocols For The Quantum Age

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    As there is a significant likelihood that quantum computers will be able to break the majority of current encryption methods within the next decade, organizations should make preparations now to transition to post-quantum security mechanisms, says Ryan McKenney at Orrick.

  • 2 FCA Settlements Highlight Gov't Cyber Liability Focus

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    Recent False Claims Act settlements with Comprehensive Health Care Services and Aerojet Rocketyne illustrate government contractors' growing cybersecurity liability, and underscore how important it is for companies to comply with new incident reporting regulations and live up to standing contractual obligations, say attorneys at O'Melveny.

  • What CMS E-Records Proposal Means For Hospitals

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    The Centers for Medicare & Medicaid Services has proposed significant changes to the Medicare Promoting Interoperability Program — including increasing transparency through public reporting and requiring history queries of prescription drug monitoring programs — that will have far-reaching ramifications for participating hospitals, say Christine Moundas and Gideon Palte at Ropes & Gray.

  • How To Protect Health Care Trade Secrets With Covenants

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    Post-employment restrictive covenants such as noncompetes are an effective way for health companies to protect confidential information and trade secrets, but employers must be cognizant of the rapidly changing state laws governing the enforceability of such agreements, say Erik Weibust and Katherine Rigby at Epstein Becker.

  • HSR Statistics Show Increasing Scrutiny Of Health Care M&A

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    Recent enforcement and Hart-Scott-Rodino statistics illustrate the Federal Trade Commission's growing interest in the application of federal antitrust law to health care transactions and the FTC's ability to test novel theories of harm in this area, say Amanda Wait and Vic Domen at Norton Rose.

  • New Ariz. Cyberattack Info Sharing May Be Worth The Burden

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    A recent amendment to Arizona’s data breach notification law, and similar state and federal cyber incident reporting rules, significantly burden companies that are attacked, but increased information sharing could help prevent and mitigate the damage from future data security incidents, say Christine Czuprynski and Kate Jarrett at McDonald Hopkins.