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

    5 Teva Inhaler Patents Kicked Out Of Orange Book

    A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.

  • 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

    Health Data Co. Says Rival's Request Risks Patient Security

    A healthcare data company pushed back against claims in Maryland federal court that it blocks a rival's access to nursing home patient data used to identify potential complications, saying the rival is asking to disable security measures that prevent attacks on its system.

  • 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.

  • July 03, 2024

    The State Of The Retail Industry's Healthcare Investments

    Amazon and Walgreens separately announced changes to their healthcare offerings, revealing the growing divide between retail companies as they grapple with a complicated business. Law360 Healthcare Authority looks at major retailers' recent healthcare ventures and where they stand now.

  • June 04, 2024

    Medical Board Group Keeps AI Liability Focus On Doctors

    When emergency room nurses and doctors make split-second decisions using an artificial intelligence tool, who ultimately bears responsibility if a patient winds up harmed? Recent guidance from the Federation of State Medical Boards keeps the onus squarely on doctors.

  • 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 28, 2024

    Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team

    RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.

  • 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.

Expert Analysis

  • 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.

  • Direct Claims Ruling May Alter Gov't Ties To Software Firms

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    A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.

  • What To Know About State-Level Health Data Privacy Laws

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    Companies that handle consumer health data, including those in the retail sector, should take a conservative approach when interpreting the scope of new health privacy laws in Washington, Nevada and Connecticut, which may include development of privacy notices, consent procedures, rights request response processes and processor contracts, say attorneys at Hunton.

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

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    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Hospitals Must Adapt To Growing Cybercrime Threats

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    As the tide of cybersecurity attacks targeting the healthcare industry continues to grow, hospitals and healthcare providers must take steps to protect themselves, including by replacing legacy records systems and ensuring that business associate agreements address responsibility for breaches, says Christine Chasse at Spencer Fane.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • How AI May Be Used In Fintech Fraud — And Fraud Detection

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    Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

  • What Recent Study Shows About AI's Promise For Legal Tasks

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    Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.