Digital Health & Technology
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March 11, 2025
Look To Recent FDA Trends For Drug Ad Guidance, Attys Say
Following campaign-season promises about banning drug advertising on television, the pharmaceutical industry is closely watching for signs of tighter enforcement. Food and drug attorneys caution against overlooking the Biden administration's enforcement priorities.
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March 10, 2025
Latham-Led Physical Therapy Startup Hinge Health Files IPO
Artificial intelligence-focused physical therapy startup Hinge Health Inc. on Monday filed plans for an initial public offering, represented by Latham & Watkins LLP and underwriters counsel Davis Polk & Wardwell LLP, joining a growing number of IPO prospects.
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March 10, 2025
GAO Says NIH Treated Bidders Disparately On $20M IT Deal
The U.S. Government Accountability Office has sustained a protest over a $19.9 million National Institutes of Health software development task order, finding the NIH unreasonably treated similar aspects of the protester's and awardee's bids differently.
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March 07, 2025
FDA Can Take Eli Lilly Weight Loss Drug Off Shortage List
A Texas federal judge has refused to issue an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, ruling that the U.S. Food and Drug Administration was within its authority when it removed the medication from the drug shortage list.
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March 07, 2025
Orlando Health Can't Duck Suit Over Sharing Of Patients' Data
A Florida federal judge has refused to release Orlando Health Inc. from a proposed class action accusing it of unlawfully sharing patients' private information with Meta Platforms and Google through ad tracking software, allowing several wiretap and contract claims to proceed while axing a single invasion of privacy allegation.
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March 07, 2025
Apple Prevails In Watch Tech Patent Fight At Fed. Circ.
The Federal Circuit handed Apple a significant victory Friday in a dispute that might have led to a ban on imports of its smartwatches, affirming that a competing company's heart monitor patents are invalid and vacating a conflicting U.S. International Trade Commission decision that found the watches infringed those patents.
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March 06, 2025
Apria Healthcare To Pay $6.4M To End Data Breach Litigation
Apria Healthcare LLC has agreed to pay $6.375 million to resolve a proposed class action over a pair of data breaches that affected more than 1.8 million individuals' personal data, according to documents filed in Indiana federal court, on the heels of the medical equipment provider reaching a separate deal with the state's attorney general over the incident.
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March 05, 2025
Wash. Hospital Patient's Pixel Privacy Suit Survives Dismissal
A Washington federal judge said Tuesday that a patient has shown how an Evergreen State hospital allegedly shared her personal health information by installing Facebook browser tracking tools on its website, preserving one of her claims while giving her a final shot at revising several others.
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March 05, 2025
Skin Care Tech Co. Files Ch. 11 With $400M Prepackaged Plan
Skin care and beauty technology company Cutera Inc. filed for Chapter 11 protection in a Texas bankruptcy court Wednesday with over $429 million in debt and a prepackaged debt-swap plan to cut that number by nearly $400 million.
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March 04, 2025
Apple Seeks Ban Against Masimo's Original Smartwatch
Apple has urged a Delaware federal judge to issue an injunction against a healthcare technology company found last year to have infringed two of the tech giant's design patents with its W1 smartwatch and charger, calling the defense's refusal to agree to the injunction "telling."
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March 04, 2025
Insurer Says Claims Of Illegally Tracked Info Erase Coverage
An insurer for a fertility treatment provider told an Illinois federal court that an exclusion on the disclosure of personal information precludes commercial general liability coverage for a lawsuit accusing the provider of unlawfully installing tracking technologies to collect website users' private information.
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March 03, 2025
Justices Decline Data Breach Suit Against SC Medical Center
The U.S. Supreme Court on Monday declined to review a Fourth Circuit decision that a health center cannot use federal immunity as a shield against a data breach lawsuit even though it received public funds, despite the company's warning that the ruling has created a circuit split.
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February 28, 2025
Pa. Health System Can't Compel Arbitration In Meta Pixel Suit
A terms of service link on a Pennsylvania health system's website was not sufficient to bind a patient to arbitration in his suit over the alleged disclosure of his personal information to Meta Platforms, a federal judge has ruled.
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February 28, 2025
Robotic Surgery Co. Appealing Tossed Intuitive Antitrust Case
Surgical Instrument Service Co. Inc. is appealing to the Ninth Circuit after a California federal court tossed its $140 million antitrust case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot at the end of trial.
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February 27, 2025
Harvard Pilgrim To Pay $16M To Settle Data Breach Claims
Healthcare company Harvard Pilgrim and its parent company Point32Health Inc. have agreed to pay $16 million to settle a class action over a 2023 data breach that affected nearly 3 million individuals and providers, according to a filing late Wednesday.
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February 25, 2025
Walgreens Inks $595M Deal To End COVID-19 Testing Suit
Walgreens Boots Alliance Inc. has agreed to pay $595 million to a lab testing and diagnostics company to put to rest a dispute over COVID-19 tests, according to a Monday filing with the U.S. Securities and Exchange Commission.
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February 25, 2025
A Year After Change Hack, Healthcare Still A Data 'Honeypot'
A year after a massive data breach disrupted healthcare nationwide, hospitals and other providers are engaged in an "arms race" against hackers as they navigate tough budget choices and remain vulnerable to cyberattacks.
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February 25, 2025
Masimo Aims To DQ Hueston Hennigan As Ex-CEO's Counsel
Masimo Corp. is urging the Delaware Chancery Court to disqualify Hueston Hennigan LLP from representing its founder and former CEO in a lawsuit over his quest for a $450 million payout from the medical technology company, arguing the firm has a conflict of interest.
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February 20, 2025
Warby Parker Hit With $1.5M Fine After HHS Breach Probe
The U.S. Department of Health and Human Services announced Thursday that it has imposed a $1.5 million fine on Warby Parker Inc. following a cyberattack on the eyewear manufacturer's website that exposed the protected health information of nearly 200,000 customers.
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February 20, 2025
Fed. Circ. Backs TTAB's Denial Of Health Co.'s Proposed TM
The Trademark Trial and Appeal Board correctly denied a healthcare management company's bid to register "Formularyhub" because it's a descriptive term, the Federal Circuit said Thursday.
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February 19, 2025
Meta Should've Preserved Health Tracking Data, Judge Says
A California federal judge considering sanctions against Meta for deleting data in privacy litigation over a Facebook tool's collection of patient health information said Wednesday that he's not convinced Meta had "malintent," but said, "I do think this information should have been preserved."
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February 19, 2025
Tech Co.'s Software Doesn't Meet CMS Needs, Judge Says
A Court of Federal Claims judge denied IntelliBridge LLC's attempt to block the Centers for Medicare & Medicaid Services from seeking bidders for its hybrid cloud product engineering and operations contract, finding on Tuesday the agency isn't trying to replicate its batCAVE software.
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February 19, 2025
Walgreens Says $1B COVID Testing Award Must Be Nixed
Walgreens is urging a Delaware federal judge to rethink his decision enforcing a $987 million arbitral award to a lab testing and diagnostics company in a dispute over COVID-19 tests, arguing Tuesday that he ignored that the arbitrator "invented" language in the contract to arrive at his conclusion.
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February 18, 2025
Human Rights Atty Sees 'Serious Risks' Of Neural Data Abuse
International human rights attorney Jared Genser spoke with Law360 Healthcare Authority about the "serious risks of misuse and abuse of neurotechnologies" that have led California and Colorado to expand their state consumer privacy laws in the last year to include neural data, with similar bills pending in Montana, Massachusetts and Illinois.
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February 18, 2025
Attys Talk AI Risks, Compliance At Health Law Conference
Amid the generative artificial intelligence boom, the healthcare industry is navigating the challenge of incorporating new technology — such as automated clinical documentation and fraud detection algorithms — into their systems while anticipating enforcement action, litigation and regulatory requirements.
Expert Analysis
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What To Know About State-Level Health Data Privacy Laws
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.
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HHS' Updated Tracking Tech Guidance Offers Little Clarity
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.
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Contract Disputes Recap: Facts Differ But Same Rules Apply
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.
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Hospitals Must Adapt To Growing Cybercrime Threats
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.
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Assessing FDA Pathways For Genome-Edited Plant Foods
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.
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Spartan Arbitration Tactics Against Well-Funded Opponents
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.
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How AI May Be Used In Fintech Fraud — And Fraud Detection
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.
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What Recent Study Shows About AI's Promise For Legal Tasks
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.
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BIPA's Statutory Exemptions Post-Healthcare Ruling
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.
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What's New In FDA's Updated Data Monitoring Guidance
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.
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Keeping Up With Class Actions: Data Breach Litigation In Flux
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.
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Inside The PTAB's Seagen Cancer Drug Patent Decision
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.
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Despite Risks, AI Is A Worthy Tool For Healthcare Industry
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.