Digital Health & Technology

  • May 17, 2024

    Ga. OB-GYN Office Says Data Breach Class Action Falls Flat

    An Atlanta OB-GYN practice has urged a Georgia federal judge to dismiss a proposed class suit over a data breach that allegedly impacted the personal and protected health information of tens of thousands of patients, arguing the lead plaintiff has failed to meet the requirements of the Class Action Fairness Act.

  • May 15, 2024

    Blackbaud Dodges Data Breach Victims' Class Cert. Bid

    A South Carolina federal judge has refused to certify several proposed classes consisting of roughly 1.5 billion patients, donors and other individuals whose personal information was allegedly swept up in a 2020 ransomware attack on software provider Blackbaud Inc., finding that the plaintiffs had failed to show that class members could be easily identified. 

  • May 15, 2024

    UnitedHealth Concealed DOJ Merger Investigation, Suit Says

    UnitedHealth Group has been hit with a proposed shareholder class action alleging that it failed to disclose that the U.S. Department of Justice had reopened an antitrust investigation into the health insurance giant following its acquisition of a healthcare data company, and that top executives had sold more than $120 million of shares knowing about the investigation before a news report revealed it to the public.

  • May 14, 2024

    Under Fire For Lab Rule, FDA Remains Open To Lawmaking

    After a difficult run-up to a new federal rule on lab-developed tests, the U.S. Food and Drug Administration official overseeing medical devices voiced support Tuesday for additional lawmaking.

  • May 13, 2024

    Wash. Hospital Scores Exit In Facebook Privacy Suit, For Now

    A Washington federal judge has tossed a proposed class action accusing a Seattle-area hospital of sharing patients' confidential health information by using Facebook browser tracking tools, ruling on Monday the plaintiff has failed to show that her own private information was input into the website and shared with a third party.

  • May 13, 2024

    Philips Wants Cleaner Co. To Chip In For $1B CPAP Deal

    Koninklijke Philips NV has filed a third-party complaint in Pennsylvania federal court against SoClean Inc., which sells cleaning products for breathing devices, claiming SoClean and its parent should contribute to Philips' $1 billion settlement because its cleaners allegedly exacerbated the foam breakdown at the heart of the litigation.

  • May 10, 2024

    Retail Group Opposes $1B Arbitral Award Against Walgreens

    An advocacy group for the retail industry is backing Walgreens as it looks to set aside a nearly $1 billion arbitral award in a dispute with a COVID test maker, telling a Delaware federal judge that judicial intervention is warranted in this case.

  • May 10, 2024

    No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal

    A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.

  • May 08, 2024

    Fla. Lab Owner Gets 10 Years For Unneeded Medical Tests

    A Florida medical lab owner has been sentenced to 10 years in prison after pleading guilty to charges related to accusations that he billed Medicare for $53 million in unnecessary genetic cancer screening tests.

  • May 07, 2024

    MultiPlan, Insurance Cos. Accused Of Algorithmic Collusion

    A medical provider has lodged a proposed class action in Illinois federal court accusing MultiPlan and major insurance companies, including UnitedHealth, Aetna, Kaiser Permanente and Cigna, of using pricing tools to systematically underpay out-of-network providers.

  • May 07, 2024

    New FDA Device Rule No Cure For Unregulated Lab Tests

    The U.S. Food and Drug Administration's newly claimed authority over lab-developed tests will leave untold numbers of unregulated — and in some cases, inaccurate or otherwise faulty — tests in the hands of clinicians.

  • May 06, 2024

    Hooper Lundy Adds Government Relations Director

    An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.

  • May 03, 2024

    Ala. High Court Won't Rethink Decision On Frozen Embryos

    The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.

  • May 02, 2024

    Walgreens Fights $1B Arb. Award Over COVID Test Contract

    At-home lab test maker Everly Health urged a Delaware federal judge to affirm its nearly $1 billion arbitration award against Walgreens over claims the pharmacy chain deliberately misused the digital health platform's trademark while secretly diverting COVID-19 tests to its own pharmacists while Walgreens argued the arbitrator overstepped his authority in bestowing such an "egregious" award.

  • May 02, 2024

    Masimo Hit With Derivative Suit Over Audio Co. Acquisition

    The top brass at medical device company Masimo Corp. has been hit with a shareholder derivative action claiming they harmed the company and "confused" investors by pushing through a $1 billion acquisition of an audio equipment company, allegedly causing a steep drop in stock prices and a $5.1 billion market capitalization loss.

  • May 02, 2024

    Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.

    Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.

  • May 01, 2024

    Sens. Slam UnitedHealth's Security Lapses, Breach Response

    UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.

  • April 30, 2024

    What's Behind the Q1 Digital Health Funding Rebound

    The digital health industry saw a resurgence in funding at the start of 2024, driven by a handful of mega-rounds and growing deal sizes across the board, but it also faced record-low deal counts as investors signaled pickier attitudes over which ventures they're choosing to fund.

  • April 30, 2024

    Patients Sue NC Plasma Donation Co. Over Data Breach

    A plasma collection company has been hit in North Carolina federal court with at least two proposed class actions as of Monday claiming it failed to safeguard patient data, resulting in a breach in which names, Social Security numbers, addresses and treatment information were allegedly exposed by hackers.

  • April 30, 2024

    Tougher Privacy Rule Won't End Abortion Data Fight

    Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.

  • April 29, 2024

    UnitedHealth's Cyberattack Response Is 'Inadequate,' AGs Say

    Nearly two dozen state attorneys general urged UnitedHealth Group and its subsidiary Change Healthcare "to do more" to address the fallout from a February cyberattack by Russian ransomware group Blackcat that breached their systems and services, noting their response efforts to the outage "have been inadequate."

  • April 29, 2024

    Amid Backlash, FDA Extends Control For Lab-Developed Tests

    The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.

  • April 29, 2024

    AI Pharma Co. Sued By Investor Over Handling Of Fired CEO

    Artificial intelligence-driven pharmaceutical company Exscientia PLC has been hit with a proposed class action alleging its former CEO engaged in inappropriate personal relationships with employees, and that the company's chairman knew but concealed it.

  • April 29, 2024

    Philips Inks $1.1B Deal To Resolve CPAP Injury Claims

    The plaintiffs' attorneys leading a multidistrict litigation against Koninklijke Philips NV and some of its American subsidiaries announced Monday that they had reached a $1.1 billion settlement agreement for plaintiffs claiming that degraded foam in their breathing machines caused them personal injuries or will require long-term medical monitoring.

  • April 26, 2024

    Ill. Hospital Wins Dismissal Of Genetic Privacy Case

    An Illinois state court judge has thrown out a proposed class action accusing Advocate Health and Hospitals Corp. of violating the state's decades-old genetic information privacy law, saying Wednesday the lead plaintiff not only released the hospital system from liability, but was largely asked about her own medical status after she was already offered a job.

Expert Analysis

  • 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.

  • BIPA's Statutory Exemptions Post-Healthcare Ruling

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    The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.

  • What's New In FDA's Updated Data Monitoring Guidance

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    The U.S. Food and Drug Administration's new guidance on the use of data monitoring committees in clinical trials is set to replace the agency's 2006 guidance on the topic, with notable updates including stronger language indicating a more stringent stance against financial conflicts of interest and adaptation to recent changes in DMC structure, say attorneys at Hogan Lovells.

  • Keeping Up With Class Actions: Data Breach Litigation In Flux

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    In this monthly look at notable class action decisions, Gerald Maatman at Duane Morris examines a recent mixed-bag data breach ruling from an Illinois federal court — in the context of case law developments over the last year — which illustrates the range of issues confronting litigants going forward.

  • Inside The PTAB's Seagen Cancer Drug Patent Decision

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    The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.

  • Despite Risks, AI Is A Worthy Tool For Healthcare Industry

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    Artificial intelligence appears to provide a productive path forward for the healthcare industry, improving economic and human health outcomes, though companies must continue to address certain technology and compliance pain points, says Sarah Abrams at Bowhead Specialty Underwriters.