Digital Health & Technology

  • 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."

  • 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.

Expert Analysis

  • 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.

  • 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.