Digital Health & Technology

  • June 24, 2024

    $2.9M Health Co. Data Breach Settlement Gets Final Approval

    A Michigan federal judge has given final approval to a $2.9 million deal for a maker of prosthetics and orthotics to settle claims the company didn't protect customers' sensitive information from a cyberattack.

  • June 20, 2024

    Web-Tracking Guidance Exceeded HHS' Authority, Judge Says

    A Texas federal judge ordered the Biden administration Thursday to rescind its new guidance restricting hospitals' use of online tracking technology, declaring that federal officials had overstepped their authority by redefining what they consider protected health information.

  • June 18, 2024

    Novant Pays $6.7M For Sharing Patient Data With Facebook

    A North Carolina federal judge on Monday gave the final seal of approval to a proposed $6.7 million deal resolving litigation alleging Novant Health Inc. shared sensitive patient data with Facebook, certifying a nationwide settlement class of roughly 1.3 million individuals.

  • June 18, 2024

    COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit

    A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.

  • June 18, 2024

    Gene Therapy Co. Taps Experienced Bioscience Legal Chief

    Kriya Therapeutics Inc., which develops gene therapies to address common diseases, said Tuesday it has chosen a veteran bioscience general counsel to be its chief legal officer.

  • June 17, 2024

    Calif. Becomes Last State To Ink Deal Over Blackbaud Breach

    Blackbaud Inc. has agreed to pay $6.75 million to resolve data security claims brought by California's attorney general, who was the only one to sit out a nearly $50 million settlement that the software provider reached last year with every other state over a 2020 ransomware attack that affected thousands of its customers.

  • June 17, 2024

    Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme

    The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.

  • June 13, 2024

    IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work

    A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.

  • June 10, 2024

    Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On

    Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.

  • June 10, 2024

    Medical-Aesthetic Device Rivals Set For Sept. Poaching Trial

    A Boston federal judge on Monday scheduled a post-Labor Day jury trial for medical-aesthetic device company Cynosure's $78 million poaching lawsuit against rival Reveal Lasers, urging the parties to streamline their exhibits and damages claims.

  • June 07, 2024

    DC Circ. Undoes Library Of Congress Win In Fair Use Fight

    The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.

  • June 04, 2024

    The State Of The Retail Industry's Healthcare Investments

    Dollar General recently became the latest big retailer to back out of the healthcare space, following years of moves by major companies — from Amazon to Walmart to CVS — to enter the lucrative industry. Law360 Healthcare Authority looks at major retailers' recent healthcare ventures and where they stand now.

  • May 31, 2024

    Samsung Strikes First With Smart Ring IP Suit Against Oura

    Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings. 

  • May 30, 2024

    FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security

    The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit. 

  • May 30, 2024

    Veradigm Execs Sued Over Company's Nasdaq Delisting

    Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.

  • May 29, 2024

    Greenberg Traurig Adds IP Atty From Eversheds Sutherland

    Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.

  • May 24, 2024

    Fla. Lab Owner Will Pay $27M To End False Billing Suit

    A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.

  • May 23, 2024

    Stryker Unit And Seyfarth Attys Hit With $275K Sanctions

    A Colorado federal judge has imposed $275,000 in sanctions jointly and severally on Stryker-owned Howmedica Osteonics Corp., along with Seyfarth Shaw LLP, for witness coaching and discovery violations in a bitter breach-of-contract dispute, amounting to roughly one-eighth of what plaintiff ORP Surgical LLC had sought.

  • May 22, 2024

    Stryker Agrees To Settle Calif. Misclassification Suit

    Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.

  • May 22, 2024

    Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects

    Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.

  • May 21, 2024

    Amid Abortion Suit, Ind. Officials Spar Over Report Releases

    Indiana's top lawyer is set to respond to a lawsuit seeking access to doctor-created abortion reports. The case promises to highlight a rift between the state's vocally anti-abortion attorney general and other officials who say the information is off-limits to public records requests.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Ga. OB-GYN Office Says Data Breach Class Action Falls Flat

    An Atlanta OB-GYN practice has urged a Georgia federal judge to dismiss a proposed class suit over a data breach that allegedly impacted the personal and protected health information of tens of thousands of patients, arguing the lead plaintiff has failed to meet the requirements of the Class Action Fairness Act.

Expert Analysis

  • 5 Critical Factors Driving Settlement Values In Cyber Litigation

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    Recent ransomware incidents and their legal repercussions offer five valuable insights into the determinants of settlement values in cyberattack-related litigation, and understanding these trends and their implications can better prepare organizations for the potential legal fallout from future breaches, says Peter Kamminga at JAMS.

  • PBM Takeaways From Proposed Telehealth Flexibility Bill

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    The U.S. House of Representatives' proposal to extend certain telehealth flexibilities signals a robust commitment to expanding telehealth access, though its plan to offset additional expenses through pharmacy benefit manager reform could lead to some industry consolidation, say attorneys at Mintz.

  • Unpacking NY's Revised Hospital Cybersecurity Rule Proposal

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    The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Examining Illinois Genetic Privacy Law Amid Deluge Of Claims

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    After a federal court certified an Illinois Genetic Information Privacy Act class action in August, claims under the law have skyrocketed, so employers, insurers and others that collect health and genetic information should ensure compliance with the act to limit litigation risk, say attorneys at Squire Patton.

  • Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

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    The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • 8 Questions To Ask Before Final CISA Breach Reporting Rule

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    The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

  • Considering CGL Defense For Social Media Addiction Claims

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    A recent lawsuit filed in California state court against Meta seeks damages from technology companies for the costs of treating children allegedly suffering from social media addiction, but the prospects of defense coverage under commercial general liability insurance policies for a potential new wave of claims look promising, say Craig Hirsch and Tae Andrews at Pasich.

  • HHS Opioid Rule Generally Benefits Providers And Patients

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    The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.