Digital Health & Technology

  • February 28, 2024

    NuVasive Can Pierce Co. To Collect From Ex-Rep, Judge Says

    NuVasive Inc. can pierce the corporate veil to collect a $617,000-plus arbitration judgment it won against a company operated by one of its former sales representatives who improperly cut ties with the medical device company and violated his noncompete agreement, a Boston federal judge has ruled. 

  • February 27, 2024

    Last-Minute Settlement Stops 2nd Catheter Trial In Del.

    A second legal fight over patents that cover a type of external catheter for women will not be going before a jury in Wilmington after the two feuding rivals agreed on Tuesday to settle the dispute.

  • February 27, 2024

    10th Circ. Backs FDA E-Cigarettes Marketing Denial

    The Tenth Circuit on Tuesday upheld the U.S. Food and Drug Administration's denials of two companies' applications to market flavored e-cigarettes, rejecting their argument that the agency secretly planned to reject any applications without long-term studies.

  • February 27, 2024

    Survey Finds Just 4 in 10 Healthcare Orgs. Review AI Guidance

    Only 40% of healthcare professionals surveyed by the Berkeley Research Group say their organizations are reviewing or plan to review regulatory guidance on artificial intelligence, even as they expect rapid growth in AI deployment over the next three years, according to a report released Tuesday.

  • February 26, 2024

    NC Health Data Breach Class Deal Gets Preliminary OK

    A North Carolina state judge has preliminarily approved a settlement resolving a class action against an orthopedic practice over a data breach that compromised sensitive personal information and medical records of current and former patients.

  • February 26, 2024

    UnitedHealth Unit Hits 6th Day Of IT Outage After Cyberattack

    A UnitedHealth Group unit on Monday entered its sixth day of dealing with a cyberattack that breached its information technology systems and services spanning pharmacy claims billing, medical records and payor communications software.

  • February 26, 2024

    NC Hospital's Weak Data Security Led To Breach, Suit Says

    A patient filed a proposed class action in North Carolina's business court alleging a hospital system's inadequate data security resulted in a breach that allowed hackers to access private personal and health information.

  • February 23, 2024

    Seattle Hospital Gets Facebook Browser Tracking Suit Tossed

    A Washington state judge sided with Seattle Children's Hospital on Friday, throwing out a proposed class action accusing the healthcare provider of privacy law violations and agreeing the group of parents hadn't shown how the use of a browser tracking tool on its website disclosed confidential patient information to Facebook.

  • February 23, 2024

    Chamber's Report Bemoans Biden's March-In Idea For Drug IP

    The most powerful business lobbying group in the U.S. said that although the country ranked at the top of its annual International IP Index, the Biden administration's efforts to potentially use patent laws to reduce the price of pharmaceuticals would jeopardize its place down the line.

  • February 23, 2024

    Fla. Doctor Says T-Mobile Let Hacker Steal Her SIM Card

    A Tampa, Florida, doctor has sued T-Mobile for allegedly failing to stop a "SIM swap" hacker from transferring her personal phone account and then doing little to address the identity theft that followed, which involved the hacker trying to steal thousands from her retirement account and using her medical credentials to write more than 700 fraudulent prescriptions.

  • February 23, 2024

    Healthcare AI Startup Abridge Raises $150M

    AI clinical documentation company Abridge said on Friday that it had raised a $150 million series C round to build on its existing product lines and accelerate research and development.

  • February 22, 2024

    HHS' Civil Rights Office Reaches 2nd-Ever Ransomware Deal

    The Department of Health and Human Services has reached a deal with a Maryland-based behavioral health practice over a ransomware attack that affected the protected health information of nearly 15,000 individuals.

  • February 22, 2024

    HHS Warning to Congress: Health Data Breaches Surging

    The number of large data breaches exposing protected health information more than doubled in a recent five-year period, reaching 626 incidents in 2022 that affected nearly 42 million people, federal officials said Thursday.

  • February 22, 2024

    Mich. Judge OKs $52M Deal For Mayo Foundation Subscribers

    A Michigan federal judge on Wednesday gave the initial approval to a $52 million deal for subscribers to the Mayo Foundation's health magazine who allege the publisher shared their private information without consent.

  • February 21, 2024

    Del. Suit Accuses Healthcare Data Co. Exec Of Insider Trading

    A stockholder launched a derivative lawsuit late Wednesday in Delaware's Court of Chancery, alleging the founder of a behavioral healthcare data firm traded company shares using insider information and that nearly a dozen current and former directors and officers provided false and misleading disclosures about the business.

  • February 21, 2024

    Former Exec Convicted Of Medtronic Insider Trading Scheme

    A Minneapolis man who tipped off a friend about his employer's secret negotiations on a $1.6 billion acquisition deal with medical device company Medtronic has been convicted of securities fraud and conspiring to commit insider trading, the Minnesota U.S. Attorney's Office has announced.

  • February 21, 2024

    3rd Circ. Kicks Data Privacy Suit Against Penn To State Court

    A proposed class action alleging that the University of Pennsylvania violated the state's privacy law must head back to state court, the Third Circuit ruled Wednesday, rejecting arguments that the university health system acted as a federal officer by operating an online patient portal.

  • February 20, 2024

    Ala. Justices Deem Frozen Embryos Children Under State Law

    The Alabama Supreme Court ruled that frozen embryos count as children in a first-of-its-kind decision bemoaned by advocates and a dissenting judge as potentially ruinous for in vitro fertilization services in the state. 

  • February 20, 2024

    FDA Flags 'Alarming Trend' Of Bad Data In Med Device Testing

    The Food and Drug Administration warned medical device manufacturers Tuesday that it has spotted an uptick in fraudulent data submitted by applicants seeking approval for new devices, an "alarming trend" the agency said could harm patients' access to vital medical equipment.

  • February 20, 2024

    Biology AI Startup Bioptimus Raises $35M Seed Round

    Artificial intelligence startup Bioptimus has raised $35 million to build an AI foundational model focused on biology, the company announced Tuesday.

  • February 20, 2024

    Fed. Circ. Backs Microsoft's PTAB Win Over 3D Patents

    The Patent Trial and Appeal Board properly invalidated a pair of 3D medical imaging patents challenged by Microsoft, the Federal Circuit affirmed Tuesday.

  • February 15, 2024

    7th Circ. Rejects Ancestry.com's Arbitration Bid In Privacy Suit

    The Seventh Circuit on Thursday upheld a lower court's decision that minors suing Ancestry.com for sharing their genetic testing information can avoid arbitration, saying there was no language in the terms their parents signed designating the children as parties to the agreement.

  • February 15, 2024

    House Committee Blasts VA, Oracle For E-Record Failures

    Lawmakers on Thursday rebuked the U.S. Department of Veterans Affairs and Oracle Corp. for inadequate fixes to electronic medical records systems that they say continue to threaten the health and safety of thousands of veterans, who are not being advised of the risk.

  • February 15, 2024

    Med Monitoring Claims In Philips MDL Sent Back For Review

    The judge overseeing multidistrict litigation over Koninklijke Philips NV's recalled breathing machines has declined a special master's recommendation to trim claims seeking medical monitoring for some users, instead sending the case back for a deeper look at which states would allow such claims or whether they required proof of physical injury.

  • February 14, 2024

    Telehealth Advocates Press DEA On Prescription 'Red Flags'

    Several telehealth providers, policy organizations and a technology company joined forces to urge the U.S. Drug Enforcement Administration to provide "explicit guidance" to pharmacists about filling prescriptions for controlled substances that result from telehealth visits. 

Expert Analysis

  • What Circuit Split May Mean For FCA Kickback Liability

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.

    Author Photo

    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

    Author Photo

    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.

  • Why Privacy And Trade Secret Law Are On A Collision Course

    Author Photo

    The conflict between the legal regimes of trade secret law and data privacy law is growing as companies increasingly collect and use data about their customers, making it key for organizations to find ways to comply with both laws in order to protect their intellectual property and the privacy of their customer, says Jenny Colgate at Rothwell Figg.

  • Negotiating AI-Life Sciences Partnerships To Minimize IP Risk

    Author Photo

    When life sciences companies and AI companies form partnerships to foster innovation, the parties should align interests as well as mitigate intellectual property risks by strategically identifying and addressing the unique AI-related legal issues, such as training data, AI model and output, say attorneys at Finnegan.

  • Parsing Through The FTC's Proposed Health Privacy Updates

    Author Photo

    The Federal Trade Commission's recently proposed updates to its Health Breach Notification Rule contain subtle but significant changes to key terms that help modernize the agency's health app regulation and provide stakeholders an important opportunity to help shape the future of virtual health care, say attorneys at Arnold & Porter.

  • Regulating AI: An Overview Of Federal Efforts

    Author Photo

    The U.S. has been carefully managing a national policy and regulatory ecosystem toward artificial intelligence, but as AI technology continues to expand into our everyday lives, so too has its risks and the need for regulation, says Jennifer Maisel at Rothwell Figg.

  • Compliance Takeaways From HHS Information Blocking Rule

    Author Photo

    A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.

  • Life Sci Cos. Should Work With FDA To Shape AI Regulation

    Author Photo

    Due to the rapidly evolving nature of potentially long-term regulatory paradigms for artificial intelligence, drug and biologic manufacturers looking to leverage AI should engage strategically with the U.S. Food and Drug Administration to ensure clarity surrounding compliance obligations, say Lowell Zeta and Blake Wilson at Hogan Lovells.

  • BIPA, Meta Pixel Suits Could Reshape Cybersecurity Litigation

    Author Photo

    Businesses and attorneys should watch several pending electronic privacy cases that revolve around disclosure of protected personal information and health data, which may shape how courts handle damages and class actions in the future of cybersecurity litigation, say Kelly Johnson and Melanie Condon at Goldberg Segalla.