Digital Health & Technology

  • 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.

  • December 08, 2023

    New Drug Patent Proposal Sparks Worry Over Gov't Overstep

    The Biden administration's proposal to seize drug patents if the prices of the medicines are deemed unreasonable is expected to face significant legal pushback, and the potential effects on the pharmaceutical industry may not be what the administration had in mind, experts say.

  • December 07, 2023

    NC Radiology Group, Broker Strike Deal In Cyberattack Row

    A North Carolina radiology practice told a federal court Thursday it struck a deal with its insurance broker resolving its suit alleging it lost more than $1 million as a result of a ransomware attack that occurred shortly after the broker allowed cyber liability coverage to lapse.

  • December 06, 2023

    Wellness or Medical? Device-Maker Attys Look for Answers

    To be or not to be a medical device? That is the question attorneys are navigating with healthcare entrepreneurs seeking to market innovations incorporating artificial intelligence and digital technologies, and one that may help them avoid conflicts with U.S. Food and Drug Administration guidelines.

  • December 06, 2023

    Hospital Group Explores 'Responsible' Health Data Privacy

    The Joint Commission, a healthcare accreditation nonprofit, launched a new health data privacy certification program on Wednesday that aims to train hospitals on protecting patient privacy while transferring the data to third-party organizations for secondary use.

  • December 06, 2023

    HHS Offers Plan To Bolster Hospital Defenses In Cyberattacks

    The Centers for Medicare and Medicaid Services will propose new cybersecurity requirements for hospitals in an effort to implement greater accountability in the healthcare industry, the federal government announced Wednesday.

  • December 06, 2023

    NC Biz Court Trims Suit Claiming Hospital Sold Data To Meta

    North Carolina's business court allowed a proposed class action against WakeMed Health & Hospitals to move forward after finding the plaintiffs adequately alleged claims of common-law negligence, breach of implied contract and breach of fiduciary duty in a suit claiming the hospital system sold patient data to Meta Inc. without consent.

  • December 05, 2023

    Massive Hack At 23andMe Got Health, DNA Ancestry Data

    Hackers accessed data from about 6.9 million users of the DNA testing company 23andMe Inc., the company confirmed Tuesday. The breach got a wealth of sensitive information, including health and DNA ancestry profiles.

  • December 04, 2023

    Patients Sue Nevada Healthcare Vendor For Exposing Data

    Two patients of an Illinois healthcare system filed a proposed class action against a Nevada medical transcription firm, alleging that the company failed to protect sensitive health information, even though the healthcare sector is a favorite target for hackers.

  • December 04, 2023

    Blank-Check Co. Aimei Health Technology Prices $60M IPO

    Aimei Health Technology, a blank-check company focused on healthcare targets, priced its initial public offering at $60 million on Friday ahead of its Monday listing on the Nasdaq, offering 6 million units at $10 apiece.

  • November 30, 2023

    MOVEit Hack MDL Needs 'Structure,' Judge Tells Atty Gaggle

    A federal district judge tapped to oversee the multidistrict litigation in a massive data breach involving Progress Software Corp.’s MOVEit transfer program told dozens of lawyers in a packed Massachusetts courtroom Thursday that she plans to choose class leaders by the beginning of January.

  • November 29, 2023

    House Told AI Is A Tool, Not A Decision Maker, In Health Care

    Amid expanding innovations in artificial intelligence in the health care industry, from AI scribes of patient visits to algorithm-driven medical imaging, experts are urging lawmakers to develop regulation and oversight to avoid compromising patient safety and privacy.

  • November 29, 2023

    Investors Say Co. Lied About Ultrasound Tech Prior To Merger

    A pair of shareholders in digital health company Butterfly Network Inc. have launched a derivative suit against the company's current and former top brass, alleging they drastically inflated the company's sales projections and the quality of its main ultrasound product to convince investors to approve a merger with a special-purpose acquisition company.

  • November 29, 2023

    Gov't Contracts Of The Month: Boeing Jets, Robots, IT Deals

    The federal government advanced a $2.5 billion plan to modernize the Indian Health Service's health records system, purchased $2.3 billion more of refueling tankers from Boeing, and is weighing adding robots to its $132 billion fast-paced construction of new nuclear submarines. Here are Law360's top government contracts for November 2023.

  • November 29, 2023

    Patients Lack Standing To Sue Over Email Hack, Ill. Court Says

    An Illinois state appeals court has affirmed the dismissal of two proposed class actions from patients who alleged a large, physician-owned medical group in Illinois failed to safeguard patient data and allowed a hacker to steal information that may include patient Social Security numbers and medical information.

  • November 22, 2023

    Debevoise Attys On AI Potential In Health, 'Iterative' Mistakes

    A growing number of health insurance providers are facing lawsuits targeting their use of an artificial intelligence algorithm in online claims processing. Maura Kathleen Monaghan and Jim Pastore of Debevoise & Plimpton spoke with Law360 about AI automation in insurance claims, auditing and the need for more top-level attention to the technology.

  • November 21, 2023

    Attys Want $4.2M In Fees For Aurora Health Privacy Case

    Attorneys on Monday asked a Wisconsin federal judge to approve their request for a nearly 35% portion of a $12.25 million settlement of a suit against Advocate Aurora Health for disclosing private health information to Google and Facebook.

  • November 20, 2023

    NY-Based Hospital To Pay $80K For HIPAA Violations

    A New York-based medical center on Monday agreed to pay the U.S. Department of Health and Human Services' Office for Civil Rights $80,000 as part of a settlement after the hospital shared protected health information of COVID-19 patients to a national media outlet.

  • November 20, 2023

    Feds ID 330K More Potential Victims In Medicare Data Breach

    The U.S. Centers for Medicare & Medicaid says the personal information of an additional 330,000 patients may have been exposed in a cyberattack carried out earlier this year targeting the file-sharing tool MOVEit.

  • November 20, 2023

    Mich. Health Co. Sued Again Over Breach Spanning 2M People

    Michigan health system McLaren Health Care Corp. was hit with another federal lawsuit claiming it recklessly failed to protect its data systems from a cyberattack in August that allegedly compromised the personal information of over 2 million individuals.

Expert Analysis

  • 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.

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

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    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

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    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

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    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

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    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

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    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

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    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.