Digital Health & Technology

  • January 30, 2024

    CareFirst Judge Mulls Class OK In Trimmed Data Breach Row

    A D.C. federal judge on Tuesday appeared open to the possibility of certifying a class of CareFirst policyholders that would seek only nominal damages against the health insurer for a 2014 data breach that exposed personal information belonging to roughly 1.1 million customers.  

  • January 30, 2024

    NC Hospital Says It Didn't Share Patient Data With Meta

    A North Carolina hospital system scoffed at allegations that it shared patient information with Facebook without consent for years in response to a proposed negligence class action brought by three patients and after a state business court allowed the action to move forward.

  • January 30, 2024

    Stryker Can't Slip California Workers' Wage Suit

    Medical device company Stryker cannot escape former workers' wage claims, a California federal judge ruled Tuesday, saying it was unclear whether the company was the workers' employer because it still retained some authority over workers employed by the company's subsidiaries.

  • January 29, 2024

    Reps Want More From VA On AI Transparency, Enforcement

    Members of the House of Representatives on Monday grilled officials from the U.S. Department of Veterans Affairs on how they plan to protect veterans' privacy and ensure transparency in the development and deployment of artificial intelligence models.

  • January 29, 2024

    Meta Must Keep Battling Trimmed Health Tracking Privacy Suit

    A California federal judge on Monday refused to throw out a trimmed version of a lawsuit claiming that Meta Platforms Inc. illegally collected patients' health information using a Facebook data tracking tool, ruling that their latest complaint has addressed some of his prior concerns.

  • January 29, 2024

    Texas AG Seeks Transgender Patients' Data, Ga. Clinic Says

    Georgia-based telehealth clinic QueerMed said Monday that Texas Attorney General Ken Paxton is asking for medical records for patients seeking gender-affirming care, saying the request appears intentional to deter out-of-state clinics from providing such care.

  • January 29, 2024

    FDA Seeks Input On Reporting Race, Ethnicity In Drug Trials

    The Food and Drug Administration asked the healthcare industry Monday for comment on updated guidance that outlines the agency's expectations for collecting race and ethnicity data in drug and medical device research.

  • January 29, 2024

    Imperative Care Names O'Melveny Deals Partner As CLO

    Silicon Valley's Imperative Care announced Monday that an O'Melveny deals partner will take over as chief legal officer, joining a revamped leadership team at the medical tech company.

  • January 26, 2024

    23andMe Users Say Hackers Targeted Jewish, Chinese Data

    Hackers who pushed their way past 23andMe's security systems in a data breach last year were after the personal information of Jewish and Chinese customers, but the biotechnology company hid that detail when notifying 7 million affected customers, according to a proposed class action filed Friday in California federal court.

  • January 26, 2024

    Bills Aim To Halt Cash To Chinese Cos. Over Genetic Data

    Lawmakers on Capitol Hill have introduced legislation to block Chinese biotech companies from receiving federal funding if they have ties to the Chinese Communist Party, saying the goal is to prevent such companies and the party from stealing America's genetic data.

  • January 26, 2024

    Ex-Goodwin Procter Life Sciences Atty Joins DLA Piper In NY

    DLA Piper announced it has hired an experienced life sciences transactional attorney from Goodwin Procter LLP as a New York-based partner in its corporate practice.

  • January 25, 2024

    Morgan & Morgan Beats Firms To Lead Zoll Data Breach Row

    A Massachusetts federal judge on Thursday tapped Morgan & Morgan PA to lead a proposed class action by customers of Zoll Medical Corp. alleging the company failed to protect their private information in two data breaches, rejecting a competing bid by Hausfeld LLP and DiCello Levitt.

  • January 24, 2024

    Med Device Employee Gets 1 Year For Forging FDA Clearance

    A former worker for a medical device maker was sentenced Wednesday to a year in prison after pleading guilty to his role in selling medical equipment that did not have governmental approval.

  • January 24, 2024

    Software Co. Says Data Breach Victims Aren't Customers

    NextGen Healthcare is asking a Georgia federal court to dismiss a proposed consolidated class action because the plaintiffs don't have a relationship with the software company that would make it liable for damages, even as it acknowledged their health information was compromised by a cyberattack. 

  • January 23, 2024

    Australia, US, UK Sanction Russian Over Medibank Hack

    Officials from Australia, the U.S. and the United Kingdom revealed Tuesday that they had sanctioned a Russian national believed to have played an integral role in a 2022 cyberattack that hit Australian health insurer Medibank Private Ltd., marking the first time the three nations have made such a coordinated strike. 

  • January 23, 2024

    FDA Pilot Program Accepts First AI Health Technology

    An automated depression and anxiety severity measurement tool is the first artificial intelligence-based and digital health technology-based project as well as the first neuroscience project accepted into the U.S. Food and Drug Administration's Innovative Science and Technology Approaches for New Drugs Pilot Program, or ISTAND, the agency announced Tuesday.

  • January 22, 2024

    NY Senate Backs Bill Bolstering Healthcare Data Privacy

    New York state's Senate on Monday signed off on legislation that would require companies collecting and selling healthcare information to have user consent before selling that data to third parties, passing a bill that's part of a legislative package lawmakers say is aimed at "reproductive equity."

  • January 22, 2024

    Anna Jaques Hospital Sued In Mass. Over Hacked Patient Data

    Anna Jaques Hospital was hit with a proposed class action on Monday in Massachusetts state court alleging the hospital failed to maintain adequate cybersecurity measures, leading to a December breach potentially involving thousands of patient records.

  • January 22, 2024

    4th Circ. Preview: Timberland's TM Bid Kicks Off 2024

    The Fourth Circuit will kick off 2024 by probing Timberland's bid to trademark its footwear and pondering an embattled insurance mogul's attempt to escape a $524 million judgment.

  • January 22, 2024

    Boston Biopharma Co. Picks Industry Veteran As Next GC

    Biopharma company BPGbio Inc. announced Monday the appointment of a compliance specialist and former Cooley LLP associate as its new general counsel.

  • January 19, 2024

    Law360 Names Firms Of The Year

    Eight law firms have earned spots as Law360's Firms of the Year, with 55 Practice Group of the Year awards among them, steering some of the largest deals of 2023 and securing high-profile litigation wins, including at the U.S. Supreme Court.

  • January 19, 2024

    Law360 Names Practice Groups Of The Year

    Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2023, which honor the attorney teams behind litigation wins and major deals that resonated throughout the legal industry this past year.

  • January 19, 2024

    Lawmakers Urge HHS To Make Telehealth Policy Permanent

    A bipartisan group of senators and representatives on Friday pressed the U.S. Department of Health and Human Services to make permanent the temporary pandemic-era expansions in Medicare telehealth coverage before the end of the year.

  • January 19, 2024

    Colo. Group Seeks Damage Caps Drop, Reporting Expansion

    An issue committee, supported in part by the Colorado Trial Lawyers Association, has launched an effort to place two statewide initiatives before Colorado voters in November, designed to help patients and those filing suits over catastrophic injuries and wrongful deaths.

  • January 19, 2024

    Becton Investors Get Initial OK Of $85M Deal Over Recall

    A magistrate judge granted preliminary approval to an $85 million settlement a class of Becton Dickinson investors reached with the medical tech company over securities fraud claims that it hid regulatory problems regarding sales of its Alaris infusion pump, which Becton recalled in 2020.

Expert Analysis

  • Medicare Developments Ahead For Remote Health Monitoring

    Author Photo

    Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.

  • Calif. Privacy Law Holds Implications For Mental Health Apps

    Author Photo

    California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.

  • New Clinical Trial Law Promotes Diversity And Modernization

    Author Photo

    The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.

  • Evaluating The Legal Ethics Of A ChatGPT-Authored Motion

    Author Photo

    Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.

  • 2022 Law And Policy Highlights In Digital Health Care

    Author Photo

    This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.

  • Next Compliance Steps For Health Cos. Using Tracking Tech

    Author Photo

    In light of the U.S. Department of Health and Human Services Office for Civil Rights' expansive view of what constitutes protected health information, regulated entities seeking to provide websites and mobile apps for patients may need to choose between several imperfect compliance pathways if they wish to continue using tracking technologies, say attorneys at Ropes & Gray.

  • Top Trends And Challenges For Health Care Financing In 2022

    Author Photo

    Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.

  • 2022 Data Privacy Suits Tested New Liability Theories

    Author Photo

    In the absence of a comprehensive federal data privacy law, plaintiffs lawyers are testing new theories of liability under state laws, and a look at recent lawsuits against online companies that have resulted in large settlements shows these attempts are more frequently being met with success, say attorneys at Quinn Emanuel.

  • How EU's New Pharma Incentives May Affect US Cos.

    Author Photo

    Geneviève Michaux and Georgios Symeonidis at King & Spalding examine Europe's recent revisions to its General Pharmaceutical Legislation and the Orphan and Paediatric Legislation, and consider the European Commission's related policy proposals, with an emphasis on pharmaceutical incentives and impacts for U.S. pharmaceutical developers and manufacturers that market products in Europe.

  • HHS Bulletin Raises HIPAA Risks For Online Tracking Vendors

    Author Photo

    A new bulletin from the U.S. Department of Health and Human Services clarifies how the Health Insurance Portability and Accountability Act applies to information collected by tracking technology on websites and mobile apps, creating new compliance considerations for online tracking vendors that may be unfamiliar with HIPAA, says Mason Fitch at Hintze Law.

  • Compliance Considerations For Virtual Ketamine Clinics

    Author Photo

    In the wake of investigations into several online prescribers of controlled substances, it is more important than ever that virtual clinics providing off-label ketamine treatment for mental and behavioral health issues consider five key aspects to staying compliant with medical practice and controlled substance regulations, say attorneys at Goodwin.

  • State Regulation Compliance Tips For Telehealth Employers

    Author Photo

    Nondisclosure, onboarding and reimbursement challenges are behind many remote work-related telehealth employment lawsuits, but with advance planning and knowledge of the state's requirements where practitioners are located, telehealth employers can avoid costly mistakes from the inception through the end of employment, say attorneys at Foley & Lardner.

  • 9 Legal Ethics Considerations In Natural Disaster Preparation

    Author Photo

    Since natural disasters like Hurricane Ian do not relieve lawyers of their ethical obligations to clients, law firms should focus their preparedness efforts on specific areas crucial to continuity of representation and ethics compliance, like business and communications contingency planning, record redundancy and more, says Mark Hinderks at Stinson.