Digital Health & Technology

  • 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."

  • December 19, 2023

    Indicted Stimwave CEO Hit With $41M Civil Suit From SEC

    The U.S. Securities and Exchange Commission on Tuesday accused the former CEO of bankrupt medical device maker Stimwave Technologies of defrauding investors out of roughly $41 million, filing a civil suit against the embattled executive the same day federal prosecutors lodged a superseding indictment in her criminal case.

  • December 19, 2023

    Fla. Nurse Convicted Of Medicare Fraud Faces Up To 21 Years

    Federal prosecutors have asked a judge to sentence a nurse practitioner in Florida to roughly 17 to 21 years in prison for her role in a Medicare fraud ring, describing her as the nation's top prescriber of fraudulent genetic tests.

  • December 19, 2023

    Philips Unit Inks $14.7M FCA Deal For Cardiac Monitoring Bills

    Philips-owned BioTelemetry Inc. and its subsidiary will pay over $14.7 million to settle False Claims Act allegations that they inflated federal healthcare reimbursements for six years by inducing providers to bill for cardiac telemetry instead of the cheaper cardiac event monitoring services doctors had intended, the U.S. Department of Justice announced Monday.

  • December 19, 2023

    Zymergen Gets Conditional OK For Ch. 11 Asset Sales

    A Delaware bankruptcy judge on Tuesday signaled she would approve biotechnology company Zymergen's asset sales to two bidders as part of its Chapter 11 liquidation plan, under an agreement whereby the debtor's parent will acquire most of the business.

  • December 18, 2023

    Claims Court Says Military Did Not Infringe Software Rights

    A U.S. Court of Federal Claims judge has ruled that the U.S. Defense Health Agency did not infringe copyrights or breach the contract of a healthcare consulting services company because the business' registrations were invalid, and there was no proof of a deal.

  • December 18, 2023

    Optum Group To Pay $160K After Patient Records Complaints

    Optum Medical Care of New Jersey has agreed to pay $160,000 to resolve allegations it violated federal law by taking too long to release health records requested by patients and parents, federal officials say.

  • December 15, 2023

    Ky. Hospital Didn't Do Enough To Stop Data Breach, Suit Says

    A Kentucky-based healthcare system that suffered a ransomware attack in May was hit with a proposed class action alleging it irresponsibly left about 2.5 million people vulnerable to identity theft, credit card fraud and other crimes.

  • December 15, 2023

    Artis Ventures Closes $200M Fund For TechBio Investments

    Venture capital firm Artis Ventures announced Thursday that it has closed a new fund, raising more than $200 million to be invested in companies focused on using technology to solve healthcare challenges.

  • December 15, 2023

    Boston Scientific Reaches $38.5M Deal To End Investor Suit

    Investors suing Boston Scientific Inc. for touting a heart valve product that was later pulled from the market announced Friday that they have settled their stock suit against the medical device maker for $38.5 million.

  • December 14, 2023

    New HHS Rule Called 'Significant Step' For Responsible AI

    The U.S. Department of Health and Human Services finalized its rule to address artificial intelligence on Wednesday, specifically taking aim at algorithm transparency and information sharing for healthcare providers, with the national coordinator for Health IT calling it a "significant step."

  • December 14, 2023

    CVS Health, 27 Others Pledge Safe AI Use And Development

    CVS Health, Duke Health and 26 other healthcare providers and payors have pledged their commitment to the "safe, secure and trustworthy" use and purchase of artificial intelligence, according to a Thursday announcement by the Biden administration.

  • December 13, 2023

    6 Biggest Healthcare Fraud Cases Of 2023

    This year saw a rare False Claims Act jury trial that netted a $490 million verdict, a $172 million settlement from Cigna to settle healthcare fraud allegations, and emerging fraud schemes from developing technologies. Here, Law360 takes a look back at six significant healthcare fraud enforcement actions from 2023.

  • December 12, 2023

    Ex-Dow Jones Atty Joins Weight Loss Co. Noom As GC

    An attorney who provided in-house counsel to Dow Jones for over two decades has joined weight loss company Noom, where he will lead compliance efforts as general counsel.

  • December 12, 2023

    Point32Health Promotes Veteran Healthcare Atty As CLO

    Susan A. Kee is the new chief legal officer at Massachusetts-based Point32Health, a not-for-profit health services organization formed three years ago from the merger of Tufts Health Plan and Harvard Pilgrim Health Care.

Expert Analysis

  • 5 Steps For Counsel Managing Health Care Data Breaches

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.

  • Anti-Kickback Safe Harbors May Be Less Safe After Medtronic

    Author Photo

    A California federal court's recent order denying dismissal in U.S. v. Medtronic improperly acknowledges intent as a liability factor in a suit alleging violations of the Anti-Kickback Statute, which is likely to erode certainty in statutory AKS safe harbor protections, says Scott Landau at Abell Eskew.

  • How Health Care Cos. Can Prepare For DOJ's Cyberfraud Push

    Author Photo

    Enforcement of the U.S. Department of Justice’s new cyberfraud initiative will initially occur largely through civil investigations that broadly apply the False Claims Act, so health care organizations should ensure that their practices can withstand hacks, whistleblowers and government scrutiny, say Katie McDermott and Mark Krotoski at Morgan Lewis.

  • How Investors Can Navigate A Vibrant Digital Health Market

    Author Photo

    With investment activity surging across the digital health care industry, investors must balance their interest in transformative technologies with the inherent risks of platforms and models that have yet to be fully proven, says Brian Gordon at McDermott.

  • What Cos. Can Learn From The 2021 FCA Recovery Statistics

    Author Photo

    Attorneys at Winston unpack the recently released U.S. Department of Justice False Claims Act recovery statistics for fiscal year 2021, discuss how they compare to prior years and what companies in an expanding array of industries should expect next.

  • Expect Aggressive Life Sciences Enforcement In 2022

    Author Photo

    This year, life sciences companies should prepare for heightened activity from the U.S. Department of Justice and U.S. Food and Drug Administration, which will likely target illicit opioid distribution, clinical trial fraud and other key areas, say attorneys at Ropes & Gray.

  • The Rising Demand For Commercial Litigators In 2022

    Author Photo

    Amid broken supply chains, pandemic-induced bankruptcies and a rise in regulation by litigation, strong commercial litigators — strategists who are adept in trying a range of tortious and contractual disputes — are becoming a must-have for many law firms, making this year an opportune moment to make the career switch, say Michael Ascher and Kimberly Donlon at Major Lindsey.

  • Health Care Policy Priorities To Watch In 2022

    Author Photo

    The Build Back Better Act is at the forefront of Congress' lengthy health care agenda this year, but there are a number of other issues that health companies and their legal teams should watch closely, including the pandemic's continuing impact on telehealth licensure requirements, surprise-billing regulations and increasing scrutiny of market consolidation, say Miranda Franco and Robert Bradner at Holland & Knight.

  • The State Of FDA Regulation Of Software As A Medical Device

    Author Photo

    Though the U.S. Food and Drug Administration has accelerated activities related to software as a medical device, developers should carefully consider guidance gaps and challenges regarding transparency and change management in software that utilizes artificial intelligence and machine learning, says Nicholas Diamond at C&M International.

  • What DOJ's Cyberfraud Initiative Means For Health Cos.

    Author Photo

    Though the U.S. Department of Justice's new cyberfraud initiative does not single out the health care industry, health and life sciences companies may be subject to heightened scrutiny under the False Claims Act and should prepare accordingly, say attorneys at Ropes & Gray.

  • How Medical Device Cos. Can Limit Enforcement, Legal Risks

    Author Photo

    With recent cases highlighting the myriad consequences that compliance failures can bring to medical device manufacturers, it is imperative that companies take proactive steps to avoid U.S. Food and Drug Administration enforcement and pay particular attention to keeping warning letters out of evidence in product liability suits, say attorneys at Phillips Lytle and Compliance Team.