Digital Health & Technology

  • February 15, 2024

    Med Monitoring Claims In Philips MDL Sent Back For Review

    The judge overseeing multidistrict litigation over Koninklijke Philips NV's recalled breathing machines has declined a special master's recommendation to trim claims seeking medical monitoring for some users, instead sending the case back for a deeper look at which states would allow such claims or whether they required proof of physical injury.

  • February 14, 2024

    Telehealth Advocates Press DEA On Prescription 'Red Flags'

    Several telehealth providers, policy organizations and a technology company joined forces to urge the U.S. Drug Enforcement Administration to provide "explicit guidance" to pharmacists about filling prescriptions for controlled substances that result from telehealth visits. 

  • February 14, 2024

    Mo. Hospital Faces Action Over Breach Of 500K Patients' Data

    A Missouri hospital has been hit with a proposed class action after allegedly taking five months to notify more than 500,000 patients that their sensitive information had been compromised, according to a complaint filed in Missouri federal court.

  • February 14, 2024

    NYC Sues Facebook, Social Media Cos. Over Teen Addiction

    New York City on Wednesday became the latest government entity to accuse social media giants such as Facebook, TikTok and YouTube of purposefully hooking youth on their platforms and driving a mental health care crisis by designing their apps to mimic gambling and tobacco industry tactics in a California state court suit.

  • February 14, 2024

    Software Co. Inks $4M Deal In Privacy Suit Over Breached Info

    Patients suing software company Connexin Software for allegedly failing to safeguard the healthcare and personal identifiable information of more than 200,000 people compromised during a data breach, including that of children, asked a Pennsylvania federal judge on Wednesday to approve a $4 million class settlement.

  • February 14, 2024

    Dad Sues Hacked Chicago Children's Hospital Again

    A plaintiff already suing Ann Lurie Children's Hospital over alleged negligence in managing its medical records has again targeted the Chicago hospital, claiming it didn't do enough to protect patient data from hackers who have stymied hospital operations for weeks. 

  • February 13, 2024

    LabCorp Sued Over Sharing Sensitive Health Info With Google

    The Laboratory Corporation of America shares sensitive health information and website browsing history with Google without patients' knowledge or consent, according to a proposed class action filed Tuesday in Pennsylvania federal court.

  • February 13, 2024

    Billing Cos. Deny Claims By Health Facility In $7M Fraud Case

    Three medical billing companies are fighting a suit by a mental health treatment facility alleging their "incompetence" cost it roughly $7 million in lost revenue and damages, telling a Connecticut federal judge that the facility wrongly terminated their agreement.

  • February 13, 2024

    Texas Appeals Court Grants Medical Coding Co.'s Atty Fee Bid

    A Texas appellate panel has ordered a diagnostics business to pay a medical coding company's attorney fees following a contract dispute between the companies, issuing a judgment Tuesday that also affirmed a trial court's decision to grant the coding company summary judgment.

  • February 13, 2024

    Nava Health To Go Public Via $320M SPAC Merger

    Health clinic chain Nava Health is planning on going public through a merger with blank-check company 99 Acquisition Group in a $320 million deal led by two law firms, the companies announced Tuesday.

  • February 13, 2024

    Convicted NC Doctor Can't Get Recordings From Prosecutors

    A North Carolina federal judge on Tuesday rejected a doctor's attempt to force prosecutors to turn over recorded phone calls with a telemedicine provider, finding that the requested materials weren't relevant and that she was trying to "manufacture" a way to have her fraud conviction overturned.

  • February 12, 2024

    GAO Says Ambiguity Protest Too Late In HHS Comms Deal

    A Virginia-based communications firm lost out on a marketing contract for the U.S. Department of Health and Human Services after the U.S. Government Accountability Office ruled that it had not provided a required rate agreement in its quote.

  • February 12, 2024

    FDA Seeks Comment On Guidance For Clinical Trial Sponsors

    The U.S. Food and Drug Administration is set to publish draft guidance on Tuesday that aims to help clinical trial sponsors determine when they need to bring in a group of data experts to review the information being collected in a clinical trial. 

  • February 09, 2024

    Healthcare Cybersecurity Bill Puts Focus On HHS Oversight

    Members of a U.S. Senate cybersecurity commission introduced a bill Friday that would require federal health officials to conduct regular evaluations of digital security systems and issue biennial reports to Congress.

  • February 09, 2024

    Mental Health App Says Former Exec Can't Lead Rival

    Therapy app company SonderMind Inc. has filed a lawsuit in Denver state court alleging a former chief medical officer is violating a non-compete clause he signed by taking an identical role at rival company Rula Health.

  • February 09, 2024

    HHS Establishes Rule For Release Of Substance Use Records

    Records of a patient's substance use treatment may be more easily shared among healthcare providers under a massive new rule issued by the U.S. Department of Health and Human Services, a step the agency said will help coordinate and improve patient care.

  • February 09, 2024

    23andMe Led To Late Father And $28M Verdict, Woman Says

    A Massachusetts woman's successful quest to learn her father's identity through the ancestry-tracking company 23andMe took a surprising turn when she later learned her new flesh-and-blood relatives left her out of her father's wrongful death suit that resulted in a $28 million jury verdict, according to a state court lawsuit.

  • February 08, 2024

    AI Shouldn't Stay In 'Ivory Tower,' Health Experts Tell Sens.

    U.S. Senators on Thursday heard from experts from Stanford University and other institutions on how to ensure that healthcare benefits promised by artificial intelligence, from improved patient outcomes to lower costs, do not remain confined to the "ivory tower" but instead reach underresourced hospitals.

  • February 08, 2024

    Broker Hit With Suit Over Data Breach Affecting 1.5 Million

    A California insurance broker is facing a proposed class action filed Thursday in federal court accusing the company of failing to keep the health and personal information of more than 1.5 million customers safe from exposure in an August cyberattack.

  • February 08, 2024

    Conn. Doc Says Website Must Unmask Fake Online Reviewer

    A Connecticut plastic surgeon asked a state court Wednesday to force the operator of website HealthGrades.com to unmask the person who posted an allegedly fake review saying she was "disfigured" by a recent procedure.

  • February 07, 2024

    US Tells 9th Circ. Stem Cell Clinic Not Exempt From FDA Rules

    The federal government urged a Ninth Circuit panel Wednesday to revive its bid to stop a clinic from offering experimental stem cell treatments, arguing the clinic's procedures are governed by the Food, Drug and Cosmetic Act because they result in a new product that is marketed as a cure for certain diseases. 

  • February 07, 2024

    Existing Laws May Stymie AI Potential To Improve Healthcare

    Medical liability and privacy laws already in place may stall the use of artificial intelligence tools to improve healthcare delivery, a bioethics and health law expert said Wednesday.

  • February 07, 2024

    Surgical Robot Co. Sued Over Internal Burns, Death Of Patient

    A widower is suing Intuitive Surgical Inc. in Florida federal court, alleging the company hid a defect in its da Vinci surgical robots that allowed electricity to arc during his wife's surgery, burning her small intestine and leading to her death.

  • February 06, 2024

    HHS Signs $4.75M Pact With NYC Hospital Over Data Theft

    A hospital in New York City's borough of the Bronx has agreed to pay $4.75 million and implement a corrective active plan to resolve the U.S. Department of Health and Human Services' claims that Montefiore Medical Center's "multiple" potential data security failings led to an employee stealing and selling thousands of patients' protected health information, the HHS said Tuesday. 

  • February 06, 2024

    10th Circ. Affirms $4.7M Stryker Loss, But Tosses Fee Award

    A Tenth Circuit panel said on Tuesday that medical device maker Stryker is not required to indemnify a Colorado distributor for the cost of winning a lawsuit against it, according to a ruling that upheld a $4.7 million judgment against Stryker but vacated a $2.3 million fee award.

Expert Analysis

  • The Double-Edged Sword Of Using ChatGPT In Health Care

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    While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.

  • Addressing Legal Issues Raised By AI Use In Health Care

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    With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.

  • New Health Data Compliance Considerations For Pa. Lawyers

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    Given the regularity with which attorneys handle private health information, it is important for Pennsylvania firms to understand recent significant amendments to the state's data breach law, which address information not currently covered by federal law, says Mark Mattioli at Post & Schell.

  • Mitigating Risks Of Developing Drugs And Devices With AI

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    As the use of artificial intelligence in drug and medical device development advances, companies should implement five key steps to identify and mitigate areas of potential risk before regulatory frameworks catch up, say attorneys at King & Spalding.

  • Scope Of FTC's Health Info Enforcement May Expand

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    The Federal Trade Commission's proposed amendments to the Health Breach Notification Rule signal the agency's mounting efforts to regulate consumer health information beyond the reaches of the Health Information Portability and Accountability Act, which does not cover many recent health apps and technologies, say Jodi Daniel and Brandon Ge at Crowell & Moring.

  • How Attys Can Avoid Exposing Their Firms To Cyberattacks

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    Attorneys are the weakest link in their firms' cyberdefenses because hackers often exploit the gap between individuals’ work and personal cybersecurity habits, but there are some steps lawyers can take to reduce the risks they create for their employers, say Mark Hurley and Carmine Cicalese at Digital Privacy & Protection.

  • Rare FDA Move Shows Stance On Remote Monitoring Devices

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    The U.S. Food and Drug Administration's recent warning letter to iRhythm Technologies represents a relatively unprecedented degree of scrutiny to the remote monitoring device industry, say attorneys at Sheppard Mullin.

  • Tips For In-House Legal Leaders In A Challenging Economy

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    Amid today's economic and geopolitical uncertainty, in-house legal teams are running lean and facing increased scrutiny and unique issues, but can step up and find innovative ways to manage outcomes and capitalize on good business opportunities, says Tim Parilla at LinkSquares.

  • Health Providers Must Beware FCA Risks When Using AI

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    Though recent innovations in artificial intelligence can potentially bring increased productivity, greater efficiency and reduced costs to the healthcare industry, providers must take appropriate precautions to avoid risks and potential False Claims Act liability, says Sara Lord at Arnall Golden.

  • New Considerations In Med Device Cybersecurity Compliance

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    Recent guidance from the U.S. Food and Drug Administration clarifies premarket submission procedures related to medical device cybersecurity, and indicates a significant expansion in the agency's expectations surrounding risk management practices for both manufacturers and providers, says Meghna Parikh at Buchalter.

  • Federal Oversight Of AI In Healthcare Is Taking Shape

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    A recent proposed rule from the U.S. Department of Health and Human Services provides early insights into how the federal government intends to oversee artificial intelligence and machine learning in healthcare, highlighting priorities like transparency, equity and potential kickback implications, say attorneys at Hooper Lundy.

  • A Close Look At Pennsylvania's Data Breach Law Changes

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    New amendments to Pennsylvania's Breach of Personal Information Notification Act will hold state agencies to stricter notification requirements more in line with those in other states, and will allow entities to determine a breach has occurred before their notification obligations take effect, says Lauren Godfrey at Constangy.

  • Abortion Pill Rulings Will Hinder FDA Authority

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    Although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the U.S. Food and Drug Administration's approval of a commonly used abortion medication, several points made by the courts are worth considering for their potentially chilling effect on FDA authority and the challenges they may create for the life sciences industry, say attorneys at Morgan Lewis.