Digital Health & Technology

  • 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. 

  • April 16, 2024

    Healthcare Industry Sees Spate Of New Data Sharing Suits

    A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.

  • April 12, 2024

    Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm

    Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.

  • April 11, 2024

    FTC Curtails Treatment Provider's Sharing Of Health Data

    The Federal Trade Commission took its latest step Thursday to crack down on the mishandling of sensitive health information, announcing a settlement that requires a New York-based alcohol addiction treatment service to obtain affirmative consent before sharing this data with third parties and bars the company from disclosing this information for advertising purposes.

  • April 11, 2024

    Ernest Health Hit With Suit After Cybercriminal Data Breach

    A group of former Ernest Health Inc. patients has hit the Texas-based hospital system with a proposed class action after a notorious group of cybercriminals breached the company's systems, saying that the company should've done more to protect patient data in a Thursday complaint.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

Expert Analysis

  • Concerns For 510(k) Sponsors After FDA Proposes Major Shift

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    While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.

  • Address The Data Monopoly, Otherwise Tech Giants Control AI

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    It is likely that we will experience a severe monopoly on artificial intelligence systems and patents by the largest players in the tech industry, so the way we treat data needs to change, whether through the legislature, the courts or tech companies, says Pranav Katti at Barclay Damon.

  • Companies Must Dig Up Old Laws To Stay Privacy-Compliant

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    Despite the recent focus on new privacy and data security laws, companies cannot ignore existing rules that have recently been revived, amended or reinterpreted to address emerging privacy and data security challenges, says Julia Kadish at Sheppard Mullin.

  • 8 Ways Life Sciences Cos. Can Adapt To The Social Media Era

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    As pharmaceutical and medical device companies harness the powerful promotion potential of social media, they must navigate legal, regulatory and reputational risks that can be particularly challenging due to the complex framework of rules that apply to the life sciences industry, say attorneys at Troutman Pepper.

  • HHS Neuromonitoring Advisory May Have Broad Relevance

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    The Health Department Office of Inspector General's recent advisory opinion rejecting a neuromonitoring service's proposal for a shell arrangement isn't surprising, but it could be a harbinger of more warnings against problematic joint venture arrangements to come, says Mary Kohler at Kohler Health Law.

  • For Radiation Oncology Units, Cyber Vigilance Is Crucial

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    Recent cyberattacks highlight the unique cybersecurity challenges faced by radiation oncology departments and the importance of implementing policies and procedures to safeguard operations and patient data, says Paul Schmeltzer at Clark Hill.

  • How Merger Review Overhaul Could Affect Health Industry

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    For those in the health care industry considering growth and expansion strategies, the antitrust agencies' recent proposals for new Hart-Scott-Rodino rules and more complex merger guidelines will increase deal timelines, the merging parties' burden, and overall uncertainty and potential antitrust risk as to the outcome, say attorneys at Husch Blackwell.

  • What Circuit Split May Mean For FCA Kickback Liability

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    The recent circuit split on the meaning of the resulting-from provision in False Claims Act kickback cases could have significant ramifications for FCA liability, as it could affect the standard of causation that plaintiffs must meet to establish liability, say former federal prosecutors Li Yu, Ellen London and Gregg Shapiro.

  • How Health Cos. Can Brace For Tracking Tech Scrutiny

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    A joint letter sent by the U.S. Department of Health and Human Services Office for Civil Rights and Federal Trade Commission last month highlights the agencies' concerns about tracking technologies, and may foreshadow a spike in enforcement actions, say attorneys at Moses Singer.

  • Unpacking CMS' Latest Proposals For Telehealth Flexibilities

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    The Centers for Medicare and Medicaid Services' calendar year 2024 proposed rule includes a number of important extensions to telehealth flexibilities, acknowledging the importance of these temporary policies, but permanent certainty will require further legislative action and agency rulemaking, say attorneys at Baker Donelson.

  • Wash. Class Actions Are Coming After My Health My Data Act

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    With its expansive scope and private right of action — including possible class actions — for damages, Washington state’s recently enacted My Health My Data Act will be the basis for a great deal of litigation, and companies should be mindful that plaintiffs will need to prove actual, monetary harm, says Tom Nolan at Quinn Emanuel.

  • SEC Cybersecurity Rule Presents Burden For Health Care Cos.

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    A new rule from the U.S. Securities and Exchange Commission aims to increase cybersecurity resiliency, but may only force regulated entities — particularly those in the health care space — to face a far more complicated environment with increased strategic and litigation risks, say Bess Hinson and Angad Chopra at Holland & Knight.

  • Comparing US And EU Approaches To Health AI Regulation

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    Victoria Larson and Julia Cotney at Verrill Dana compare current U.S. and EU regulatory frameworks for artificial intelligence and machine learning in the healthcare industry and highlight key principles that providers and developers should be aware of.