Digital Health & Technology

  • January 31, 2024

    FDA, Health Experts Talk Int'l 'Harmonization' of AI Regulation

    Cross-border compatibility of rules for artificial intelligence-powered medical devices is critical for device makers looking to globalize their products in an evolving regulatory landscape, legal and governmental experts said Wednesday.

  • January 31, 2024

    Northwell Health Sued Over Breach Of 3M Patients' Data

    Northwell Health Inc., New York state's largest health care system, breached its duty to protect sensitive information by failing to keep safe the data of over 3 million individuals in a breach, according to a proposed class action filed Tuesday.

  • January 31, 2024

    Teladoc Illegally Sends Users' Personal Info To Meta, Suit Says

    Teladoc users have filed a putative class action in New York federal court accusing the virtual healthcare giant of privacy invasion for allegedly using a tracking pixel on its website to secretly wiretap their communications and activities, then subsequently sharing their personal information with Facebook without their permission.

  • January 31, 2024

    Lab Says $7M Stolen Data Is Property And Should Be Covered

    A national medical testing lab told a Pennsylvania federal court that patient treatment records and at least $7 million of billing data allegedly hijacked by its software contractor was property and should therefore be covered by its insurer. 

  • January 31, 2024

    Fla. Man Avoids Jail In Telemedicine Fraud Suit

    A Florida resident did not receive prison time during a federal court hearing Wednesday and instead was sentenced to a period of supervised release for his role in a company that prosecutors say was built to scam insurers into paying millions of dollars for prescriptions that patients didn't need.

  • 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.

Expert Analysis

  • Overcoming Immunity Of Foreign Gov't Cyberattack Sponsors

    Author Photo

    To combat the emerging threat of foreign state-sponsored cyberattacks on U.S. businesses and citizens, litigants need to creatively argue for exceptions to immunity under the Foreign Sovereign Immunities Act for foreign governments, say Jerry Goldman and Bruce Strong at Anderson Kill.

  • The State Of Consumer Class Actions Amid COVID-19

    Author Photo

    While the pandemic has slowed the filing of consumer class actions, they remain a significant part of the litigation landscape — with false labeling claims remaining particularly popular, likely because they are easy to file and frequently survive motions to dismiss, say attorneys at Skadden.

  • Anticipating The Biden Administration's Health Care Agenda

    Author Photo

    The Biden administration is unlikely to successfully push sweeping and partisan health care legislation in the next two years, but it will be able to reverse a litany of Trump administration policies pertaining to the Affordable Care Act, reproductive health care and more, say Nick Manetto and Ilisa Halpern Paul at Faegre Drinker.

  • What Biden Presidency May Mean For Data Privacy Litigation

    Author Photo

    The administration of President-elect Joe Biden will likely bring major changes to data privacy law and attendant litigation, including federal legislation that could preempt state laws, renegotiation of conditions for EU data transfers to the U.S., and increased Federal Trade Commission enforcement activity, say attorneys at Squire Patton.

  • 5 Tips For In-House Counsel Anticipating Cyber Class Actions

    Author Photo

    In light of a 270% increase in data breaches this year, and the attendant class actions, in-house counsel can prepare to efficiently manage litigation by focusing on certain initial steps, ranging from multidistrict litigation strategy to insurance best practices, say David McDowell and Nancy Thomas at MoFo.

  • Where Data Privacy And CFPB Are Headed Under Biden

    Author Photo

    Data privacy is likely to be a key area of legislative and enforcement focus for President-elect Joe Biden, and consumer financial protection is expected to be an immediate priority due to the economic impact of the pandemic, with the most drastic shift likely to occur at the Consumer Financial Protection Bureau, say attorneys at Gibson Dunn.

  • Ethics Considerations For Law Firms Implementing AI

    Author Photo

    Richard Finkelman and Yihua Astle at Berkeley Research Group discuss the ethical and bias concerns law firms must address when implementing artificial intelligence-powered applications for recruiting, conflict identification and client counseling.

  • The Legal Implications Of Mobile Health Advancements

    Author Photo

    With the pandemic rapidly accelerating the timeline for the shift to remote and mobile health care, providers will need to keep a close eye on new privacy and cybersecurity risks, and on new potential to collect real-time information from patients, say attorneys at Squire Patton.

  • The Post-Election State AG Enforcement Landscape

    Author Photo

    Election results so far have kept the number of Republican and Democratic state attorneys general even, and no matter the outcome of the presidential race, AGs will work across the aisle on important issues like health care, competition and the environment, says former Illinois attorney general Lisa Madigan at Kirkland.

  • What A Trump Or Biden Win Will Mean For State AGs

    Author Photo

    The outcome of the presidential election will have significant consequences on cooperation between federal agencies and state attorneys general, but either way robust multistate investigations — especially in the consumer protection space — will continue, says Sean Riley at Cozen O'Connor.

  • Outside Whistleblowers Are Critical To Exposing Fraud

    Author Photo

    Outsiders like industry experts, competitors, public interest organizations and concerned citizens often have deep knowledge, industry data and financial incentives that put them in a better position than insiders to spot fraud, say attorneys at Youman & Caputo, Fox Rothschild, Goldstein & Russell and Herrera Purdy.

  • Comparing Recent State Data Breach Law Updates

    Author Photo

    Public and private entities should revisit their incident response plans to ensure compliance with and understand the differences among heightened data breach notification requirements that five states and Washington, D.C., added or amended this year, says Jane Petoskey at Polsinelli.

  • Best Practices For Health Care Mergers In The COVID-19 Era

    Author Photo

    Health providers considering consolidation as a result of the pandemic's impact should attempt to mitigate antitrust enforcers' concerns by substantiating a merger with evidence of cost and quality efficiencies and making efforts to seek competition-friendly alternatives, say attorneys at Shook Hardy.