Digital Health & Technology

  • January 05, 2024

    Hospitals Want Fast End To 'Flawed' Online Tracking Rules

    The American Hospital Association and others on Friday urged a Texas federal court to scrap federal guidance effectively barring certain healthcare entities from using online tracking technology as the data captured from visitors to their websites falls "far outside" the information protected by federal health privacy law. 

  • 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.

Expert Analysis

  • 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.

  • Ransomware Risks For Health Cos. And How To Avoid Them

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    As the health care industry is a particularly valuable and vulnerable target of ransomware attacks, it's important for companies to understand possible attack methodologies and best steps for mitigating risks, says Nathan Kottkamp at Williams Mullen.

  • What FDA Expects From Medical Device Cybersecurity Efforts

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    The U.S. Food and Drug Administration's latest draft guidance on cybersecurity for medical devices highlights the distinction between safeguards that are "built in" rather than "bolted on," emphasizing the importance of robust design controls, say Jae Kim and Raymond Williams at DLA Piper.

  • As Cyber Risks Surge, Remember Attorneys' Ethical Duties

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    The prevalence of remote work and a greater threat of Russian cyberattacks should serve as a stark reminder of a lawyer's professional obligations to guard against unauthorized disclosure of client information and to protect client interests in the event of a cyberattack, says Alvin Mathews at Ulmer & Berne.

  • Seeking Clarity On Medical Privacy In Fla. Class Actions

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    When class actions are filed in Florida courts against medical service providers, even over issues other than medical treatment, and plaintiffs seek the names of other possible class members, the federal health privacy law and Florida's right to privacy are implicated — but the issue has yet to receive sufficient attention from the courts, says Aaron Weiss at Carlton Fields.

  • Navigating Ambiguities In New Cyber Reporting Law

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    The recently passed Cyber Incident Reporting for Critical Infrastructure Act requires increased cybersecurity defense and response disclosures, but owners and operators should take the law's lack of clarity on certain parameters into account as they prepare to comply, say attorneys at Holland & Knight.

  • Preparing For New Mandatory Cyber Reporting Rules

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    The requirements of a new federal law mandating cyber incident reporting for critical infrastructure will not become operational for several months, but affected companies should begin assessing whether their response plans incorporate critical policies and procedures to ensure compliance, say Steven Stransky at Thompson Hine and Lacy Rex at Oswald Companies.

  • 5 Steps For Counsel Managing Health Care Data Breaches

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    Considering the growing threat of data breaches and particular risks to health care providers and related companies, it is critical for counsel to take adequate steps to mitigate harm to patients, protect critical data, improve systems and navigate government investigations in the aftermath of a data security incident, say attorneys at K&L Gates.

  • Addressing Patient Requests For Unauthorized Treatment

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    Recent controversy over patient requests for ivermectin as COVID-19 treatment highlights the complex conversations and tricky compliance challenges that health providers must sometimes navigate when patients request nonstandard treatments, say John Dow, Kathleen Hogan and Catherine Adams at St. Peter’s Health Partners.

  • Navigating Risks In FDA's New Digital Health Tech Guidance

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    The U.S. Food and Drug Administration’s recent guidance highlights several key benefits and risks regarding the use of digital health technologies to collect data in remote clinical trials, so practitioners will need to address the legal ramifications, including potential liability and data privacy concerns, says Janice Sperow at Sperow ADR.