Digital Health & Technology

  • 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.

  • April 25, 2024

    Stryker Says Sanctions Bid Goes 'Galaxies Beyond' Law

    Medical device maker Stryker urged a Colorado federal judge to reject an ex-distributor's latest request for sanctions, arguing in a brief that the distributor's $2.2 million bid goes "galaxies beyond" what it asked for at trial and what the Tenth Circuit said the court could entertain.

  • April 25, 2024

    Judge Decries Discovery Delay In Chicago Genetic-Bias Fight

    An Illinois federal judge has warned a proposed class of Chicago employees that further discovery delays in their suit alleging a city wellness program intentionally discriminated against them on the basis of their genetic information could result in the court barring witnesses' testimony from the case.

  • April 25, 2024

    Becton BIPA Suit Gets Cut Short Under Health Exception

    An Illinois federal judge permanently tossed a Chicago health worker's biometric privacy claims targeting Becton Dickinson and Co.'s drug dispensing cabinets, saying his arguments for putting distance between his case and foreclosing precedent "border on the frivolous."

  • April 25, 2024

    Philips Gets $506M Economic Loss Deal OK'd In CPAP MDL

    A Pennsylvania federal judge on Thursday gave final approval to a $506.3 million settlement to end economic loss claims in multidistrict litigation over Philips' recalled CPAP breathing machines, including $94.4 million for the plaintiffs' attorneys.

  • April 25, 2024

    Digital Health Co.'s Former GC Joins Perkins Coie In NY

    Perkins Coie LLP is bolstering its intellectual property practice, announcing Thursday that it has brought on the former general counsel and chief compliance officer of digital healthcare company Cleerly.

  • April 25, 2024

    Wellstar Sent Meta Patient Data Without Consent, Suit Alleges

    Wellstar Health System Inc. was hit with a proposed class action in Georgia federal court, with a patient alleging the confidential health information of "millions" was shared with Meta Platform Inc. without consent after Wellstar installed the company's tracking and collection tools on its website and patient portal.

  • April 25, 2024

    Hospital Operator Must Face Data Privacy Suit In Mass.

    A Massachusetts federal judge has ordered a hospital operator to face proposed class action claims that it exposed a patient's personal information to third parties, saying the patient had a reasonable expectation of privacy.

  • April 24, 2024

    Conn. Healthcare Co. Will Pay $1.5M To End Data Breach Suit

    Merritt Healthcare Advisors has pledged a $1.525 million settlement fund for more than 88,000 people whose personal information was exposed in a data breach in 2022, with class counsel at Laukaitis Law LLC and Cole & Van Note in line to receive $508,283, according to a motion for preliminary approval in Connecticut federal court.

  • April 23, 2024

    Privacy Bill Risks Adding To Growing Health Data Patchwork

    Lawmakers behind a new data privacy framework have trumpeted the plan as a bold consumer protection regime with significant benefits for data not already covered by the Health Insurance Portability and Accountability Act. Some in the healthcare industry are less enthusiastic, saying the bill would make the privacy landscape more complicated.

  • April 23, 2024

    Colo. Neural Privacy Law Has Attys Scratching Their Heads

    Colorado's governor signed the nation's first law specifically protecting neural data last week, but privacy attorneys say key caveats in the legislation leave them unsure how far the measure really goes.

  • April 22, 2024

    Ransomware Still On Rise Despite Better Defenses, Firm Says

    Companies are becoming more adept at fending off and responding to a steady stream of ransomware attacks, but hackers' ability to continue to profit from these incidents and increased scrutiny by regulators and the plaintiffs' bar will keep pressure on companies to remain vigilant, according to a new BakerHostetler report.

  • April 22, 2024

    HHS Finalizes Rule Bolstering Abortion Privacy Protections

    The U.S. Department of Health and Human Services on Monday issued a finalized version of its new rule that aims to protect the privacy of abortion providers and patients by prohibiting the disclosure of information related to "lawful reproductive health care," according to an announcement made by the agency.

  • April 22, 2024

    Watchdog Nixes Unfair Treatment Claims In $310M VA IT Deal

    The U.S. Government Accountability Office was unconvinced that the U.S. Department of Veterans Affair graded an IT firm's bid for a $310.3 million deal more harshly than a competitor's, saying the rankings reflected differences in the bids.

  • April 19, 2024

    Edelson Pitches 'Better Way' To Pick Leads In Privacy Suits

    Plaintiffs in proposed privacy class actions should be given more say in who's picked as class counsel, in order to crack down on the "anemic settlements" that have resulted from the ineffective "old way of litigating" these matters, law firm Edelson PC argued in vying for lead counsel in a dispute over a data breach at genetics testing provider 23andMe.

  • April 19, 2024

    AI Health Data Co. Faces Investor Suit Over Accounting Issues

    Atlanta-based health data platform company Sharecare and two of its executives face accusations that they failed to disclose certain accounting issues to investors, leading to stock price declines when the issues became public, according to a shareholder suit filed Friday in California federal court.

  • April 19, 2024

    Northshore Health Worker Drops Genetic Info Privacy Claims

    A patient sitter for Northwestern HealthSystem has voluntarily dropped her proposed class suit claiming she and other workers were unlawfully required to give up information about their medical histories during the application process.

  • April 18, 2024

    Patient Data Breach Suit Should Be Tossed, Colo. Judge Says

    A judge has recommended that CommonSpirit Health be allowed to escape a proposed class action in Colorado federal court accusing it of failing to secure healthcare data leading to a breach affecting more than 600,000 patients, saying the complaint fails to "allege an injury-in-fact."

  • April 16, 2024

    House Panel Takes Aim At Change Healthcare, FTC Over Hack

    A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share. 

Expert Analysis

  • 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.

  • Potential Defendant Strategies Amid Calif. Privacy Questions

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    Although the current case law surrounding the California Consumer Privacy Act is in its infancy, courts have begun addressing important issues related to the notice-and-cure provisions of the statute, and these decisions show defendant-businesses would be wise to assert their notice rights early and repeatedly, say Viola Trebicka and Dan Humphrey at Quinn Emanuel.

  • Health Policy Legislative Landscape May Remain Frozen

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    With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

  • What Businesses Should Know About NJ Privacy Bill

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    New Jersey’s recently passed comprehensive privacy bill S.B. 332 presents businesses with a nuanced framework and compliance obligations, including opt-in consent requirements for sensitive data, with recommendations for businesses to organize data, review consent requirements and more, says Trisha Sircar at Katten.

  • Staying Ahead Of The AI Policymaking Curve

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    With artificial intelligence poised to be the hottest legislative and regulatory topic in 2024, expect the AI policymaking toolbox to continue to expand and evolve as stakeholders in the U.S. and abroad develop, deploy, use and learn more about these technologies, say attorneys at Hogan Lovells.